Diabetic Foot UlcerNCT06416462
Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot
A study testing antimicrobial photodynamic therapy in people with Diabetic Foot Ulcer, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- antimicrobial photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jul 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sexes
- chronic wounds originating from the neuropathic diabetic foot
- contaminated lesions
- total score obtained on the Bates-Jensen scale between 13 and 60
- who submits all requested exams
Who cannot join
- wounds with etiologies that are not related to the diabetic foot
- ischemic diabetic foot who has an ankle-brachial index with a value between 0.7 and 1.3.
- glycated hemoglobin greater than 8%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study
Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds.
Read the detailed description
Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds. A clinical, controlled, randomized and double-blind study will be carried out. Patients will be randomized (1:1) into 2 groups: (1) experimental (n= 45) - standard care from the Polyclinic wound sector + aPDT and (2) control (n= 45) - standard care + simulation of use aPDT with equipment off). All patients will be seen three times a week, with 10 sessions of aPDT or simulation performed by the same operator. A cluster with an average radiant power of 100 mW, radiant energy per emitter of 6 J/cm² of red light (wavelength 660 nm) will be used. The research will be carried out in a Municipal Health Center in the city of Rio de Janeiro. Patients affected by neuropathic wounds of the diabetic foot, assisted by the Programmatic Care Health Coordination will be included 5.1. The initial assessment will consist of collecting data from medical records to establish the sociodemographic and clinical profile of patients affected by diabetic foot injuries.) by a researcher blinded to the interventions. This scale assesses the size of the lesion, depth, borders, detachment, type of necrotic tissue, amount of necrotic tissue, type of exudate, amount of exudate, skin color around the wound, perilesional tissue edema, perilesional tissue hardening, granulation tissue, epithelialization. As secondary outcomes: the sensitivity of the foot will be evaluated, through neurological evaluation with tuning fork and monofilament, the instrument for assessing quality of life - Diabetes-21, the Wagner Scale, the evaluation of the degree of ischemia by the Fontaine scale and Runtherford, the WiFi and Taxonomy Nursing Outcomes Classification scale that assesses skin integrity. Data from this research will be collected after approval by the ethics committee of Universidade Nove de Julho and the City Hall of Rio de Janeiro.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- antimicrobial photodynamic therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial photodynamic therapyProcedure or surgery
When starting the research, all wounds, regardless of the study group, will be cleaned with 0.9% saline solution (SF0.9%), using a 40x12 needle and a 500ml bottle of SF0.9%, in order to maintain pressure. for equal cleaning of all wounds and a hydrofiber plate with silver was used as standard coverage. Experimental group (n=45): When starting the intervention, all services in both groups will follow the cleaning standard described previously. In the aPDT group, 1% methylene blue will be used as a photosensitizer applied with the aid of a syringe (with a pre-irradiation time of 5 minutes), 6 J of laser will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Simulation of antimicroial Photodynamic therapy group | Placebo comparator | Participants in the control group will be treated in exactly the same way as the aPDT group, however the light treatment will be simulated. The device will be placed in position, however it will be switched off. After three weeks of monitoring in the control group, the patient will be informed that they were in the placebo group and will be offered treatment with aPDT and irradiation, for ethical reasons. |
| Antimicrobial Photodynamic therapy group | Active comparator | In the experimental group (aPDT), 1% methylene blue applied with the aid of a syringe will be used as a photosensitizer (with a pre-irradiation time of 5 minutes, 6 J of red laser will be applied. Receives: Procedure: antimicrobial photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bates-Jensen Wound Assesment Tool
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization.
Each item on the scale is scored from 1 to 5:
minimum values indicate the best wound condition,
maximum values represent the worst condition.
The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Measured: Before the intervention
Bates-Jensen Wound Assesment Tool
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization.
Each item on the scale is scored from 1 to 5:
minimum values indicate the best wound condition,
maximum values represent the worst condition.
The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Measured: Day after the first session
Bates-Jensen scale
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization.
Each item on the scale is scored from 1 to 5:
minimum values indicate the best wound condition,
maximum values represent the worst condition.
The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Measured: Day after the third session
Bates-Jensen scale
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization.
Each item on the scale is scored from 1 to 5:
minimum values indicate the best wound condition,
maximum values represent the worst condition.
The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Measured: Day after the fifth session
Bates-Jensen scale
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5, where 1 indicates the best wound condition, and 5 represents the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with higher scores indicating worse wound conditions.
Measured: Day after the tenth session
Secondary outcomes (45)
Diabetes twenty-one instrument
The Diabetes-21 (D-21) instrument evaluates the quality of life of individuals living with diabetes by assessing the condition's physical, emotional, and social impacts. It consists of 21 items scored on a Likert scale, reflecting the intensity or frequency of diabetes-related challenges. The scoring ranges from a minimum of 21 to a maximum of 105. Lower scores indicate a better quality of life, suggesting fewer diabetes-related difficulties, while higher scores reflect a worse quality of life, indicating more significant challenges or negative impacts. This makes the D-21 a valuable tool for assessing the burden of diabetes in both clinical and research settings.
Measured: Before the intervention
Diabetes twenty-one instrument
he Diabetes-21 (D-21) instrument evaluates the quality of life of individuals living with diabetes by assessing the physical, emotional, and social impacts of the condition. It consists of 21 items scored on a Likert scale, reflecting the intensity or frequency of diabetes-related challenges. The scoring ranges from a minimum of 21 to a maximum of 105. Lower scores indicate a better quality of life, suggesting fewer diabetes-related difficulties, while higher scores reflect a worse quality of life, indicating more significant challenges or negative impacts. This makes the D-21 a valuable tool for assessing the burden of diabetes in both clinical and research settings.
Measured: Day after the first session
Diabetes twenty-one instrument
he Diabetes-21 (D-21) instrument evaluates the quality of life of individuals living with diabetes by assessing the physical, emotional, and social impacts of the condition. It consists of 21 items scored on a Likert scale, reflecting the intensity or frequency of diabetes-related challenges. The scoring ranges from a minimum of 21 to a maximum of 105. Lower scores indicate a better quality of life, suggesting fewer diabetes-related difficulties, while higher scores reflect a worse quality of life, indicating more significant challenges or negative impacts. This makes the D-21 a valuable tool for assessing the burden of diabetes in both clinical and research settings.
Measured: Day after the third session
Diabetes twenty-one instrument
he Diabetes-21 (D-21) instrument evaluates the quality of life of individuals living with diabetes by assessing the physical, emotional, and social impacts of the condition. It consists of 21 items scored on a Likert scale, reflecting the intensity or frequency of diabetes-related challenges. The scoring ranges from a minimum of 21 to a maximum of 105. Lower scores indicate a better quality of life, suggesting fewer diabetes-related difficulties, while higher scores reflect a worse quality of life, indicating more significant challenges or negative impacts. This makes the D-21 a valuable tool for assessing the burden of diabetes in both clinical and research settings.
Measured: Day after the fifth session
Diabetes twenty-one instrument
he Diabetes-21 (D-21) instrument evaluates the quality of life of individuals living with diabetes by assessing the physical, emotional, and social impacts of the condition. It consists of 21 items scored on a Likert scale, reflecting the intensity or frequency of diabetes-related challenges. The scoring ranges from a minimum of 21 to a maximum of 105. Lower scores indicate a better quality of life, suggesting fewer diabetes-related difficulties, while higher scores reflect a worse quality of life, indicating more significant challenges or negative impacts. This makes the D-21 a valuable tool for assessing the burden of diabetes in both clinical and research settings.
Measured: Day after the tenth session
Wagner Scale
The Wagner Scale is a classification system used to evaluate the severity of diabetic foot ulcers. It categorizes ulcers based on depth, tissue involvement, and the presence of infection or gangrene. The scale ranges from 0 to 5, with higher scores indicating more severe conditions. A score of 0 represents a pre-ulcerative lesion or intact skin, while a score of 5 indicates extensive gangrene involving the entire foot. The Wagner Scale is widely used in clinical settings to guide treatment decisions and monitor the progression of diabetic foot complications.
Measured: Before the intervention
Wagner Scale
The Wagner Scale is a classification system used to evaluate the severity of diabetic foot ulcers. It categorizes ulcers based on depth, tissue involvement, and the presence of infection or gangrene. The scale ranges from 0 to 5, with higher scores indicating more severe conditions. A score of 0 represents a pre-ulcerative lesion or intact skin, while a score of 5 indicates extensive gangrene involving the entire foot. The Wagner Scale is widely used in clinical settings to guide treatment decisions and monitor the progression of diabetic foot complications.
Measured: Day after the first session
Wagner Scale
The Wagner Scale is a classification system used to evaluate the severity of diabetic foot ulcers. It categorizes ulcers based on depth, tissue involvement, and the presence of infection or gangrene. The scale ranges from 0 to 5, with higher scores indicating more severe conditions. A score of 0 represents a pre-ulcerative lesion or intact skin, while a score of 5 indicates extensive gangrene involving the entire foot. The Wagner Scale is widely used in clinical settings to guide treatment decisions and monitor the progression of diabetic foot complications.
Measured: Day after the third session
Wagner Scale
The Wagner Scale is a classification system used to evaluate the severity of diabetic foot ulcers. It categorizes ulcers based on depth, tissue involvement, and the presence of infection or gangrene. The scale ranges from 0 to 5, with higher scores indicating more severe conditions. A score of 0 represents a pre-ulcerative lesion or intact skin, while a score of 5 indicates extensive gangrene involving the entire foot. The Wagner Scale is widely used in clinical settings to guide treatment decisions and monitor the progression of diabetic foot complications.
Measured: Day after the fifth session
Wagner Scale
The Wagner Scale is a classification system used to evaluate the severity of diabetic foot ulcers. It categorizes ulcers based on depth, tissue involvement, and the presence of infection or gangrene. The scale ranges from 0 to 5, with higher scores indicating more severe conditions. A score of 0 represents a pre-ulcerative lesion or intact skin, while a score of 5 indicates extensive gangrene involving the entire foot. The Wagner Scale is widely used in clinical settings to guide treatment decisions and monitor the progression of diabetic foot complications.
Measured: Day after the tenth session
WiFi scale
The WiFi scale is a classification system used to assess the severity of diabetic foot ulcers by evaluating three key factors: wound size and depth (W), ischemia (I), and foot infection (Fi). Each component is graded from 0 to 3, with higher grades indicating more severe conditions. The combined scores help determine the overall risk of amputation and guide treatment planning. A higher overall score indicates a worse prognosis and increased need for advanced interventions. The WiFi scale is widely used in clinical practice to stratify risk and optimize care for patients with diabetic foot complications.
Measured: Before the intervention
WiFi scale
The WiFi scale is a classification system used to assess the severity of diabetic foot ulcers by evaluating three key factors: wound size and depth (W), ischemia (I), and foot infection (Fi). Each component is graded from 0 to 3, with higher grades indicating more severe conditions. The combined scores help determine the overall risk of amputation and guide treatment planning. A higher overall score indicates a worse prognosis and increased need for advanced interventions. The WiFi scale is widely used in clinical practice to stratify risk and optimize care for patients with diabetic foot complications.
Measured: Day after the first session
WiFi scale
The WiFi scale is a classification system used to assess the severity of diabetic foot ulcers by evaluating three key factors: wound size and depth (W), ischemia (I), and foot infection (Fi). Each component is graded from 0 to 3, with higher grades indicating more severe conditions. The combined scores help determine the overall risk of amputation and guide treatment planning. A higher overall score indicates a worse prognosis and increased need for advanced interventions. The WiFi scale is widely used in clinical practice to stratify risk and optimize care for patients with diabetic foot complications.
Measured: Day after the third session
WiFi scale
The WiFi scale is a classification system used to assess the severity of diabetic foot ulcers by evaluating three key factors: wound size and depth (W), ischemia (I), and foot infection (Fi). Each component is graded from 0 to 3, with higher grades indicating more severe conditions. The combined scores help determine the overall risk of amputation and guide treatment planning. A higher overall score indicates a worse prognosis and increased need for advanced interventions. The WiFi scale is widely used in clinical practice to stratify risk and optimize care for patients with diabetic foot complications.
Measured: Day after the fifth session
WiFi scale
The WiFi scale is a classification system used to assess the severity of diabetic foot ulcers by evaluating three key factors: wound size and depth (W), ischemia (I), and foot infection (Fi). Each component is graded from 0 to 3, with higher grades indicating more severe conditions. The combined scores help determine the overall risk of amputation and guide treatment planning. A higher overall score indicates a worse prognosis and increased need for advanced interventions. The WiFi scale is widely used in clinical practice to stratify risk and optimize care for patients with diabetic foot complications.
Measured: Day after the tenth session
Nursing Outcomes Classification Taxonomy
Assess skin integrity using the Nursing Outcomes Classification Taxonomy
Measured: Before the intervention
Nursing Outcomes Classification Taxonomy
Assess skin integrity using the Nursing Outcomes Classification Taxonomy
Measured: Day after the first session
Nursing Outcomes Classification Taxonomy
Assess skin integrity using the Nursing Outcomes Classification Taxonomy
Measured: Day after the third session
Nursing Outcomes Classification Taxonomy
Assess skin integrity using the Nursing Outcomes Classification Taxonomy
Measured: Day after the fifth session
Nursing Outcomes Classification Taxonomy
Assess skin integrity using the Nursing Outcomes Classification Taxonomy
Measured: Day after the tenth session
Runtherford Scale for ischemia evaluation
Classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result.
Measured: Before the intervention
Runtherford Scale for ischemia evaluation
Classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result.
Measured: Day after the first session
Runtherford Scale for ischemia evaluation
Classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result.
Measured: Day after the third session
Runtherford Scale for ischemia evaluation
Classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result.
Measured: Day after the fifth session
Runtherford Scale for ischemia evaluation
Classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result.
Measured: Day after the tenth session
protective sensitivity of the feet through the monofilament
The protective sensitivity test using a monofilament evaluates whether an individual can feel pressure on specific points of their feet. The outcome is classified as either the presence or absence of protective sensation.
Measured: Before the intervention
protective sensitivity of the feet through the monofilament
The protective sensitivity test using a monofilament evaluates whether an individual can feel pressure on specific points of their feet. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the first session
protective sensitivity of the feet through the monofilament
The protective sensitivity test using a monofilament evaluates whether an individual can feel pressure on specific points of their feet. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the third session
protective sensitivity of the feet through the monofilament
The protective sensitivity test using a monofilament evaluates whether an individual can feel pressure on specific points of their feet. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the fifth session
protective sensitivity of the feet through the monofilament
The protective sensitivity test using a monofilament evaluates whether an individual can feel pressure on specific points of their feet. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the tenth session
protective sensitivity of the feet through tuning fork test
The protective sensitivity test using a tuning fork evaluates the ability to perceive vibration in specific points on the feet, typically at bony prominences. The outcome is classified as either the presence or absence of protective sensation.
Measured: Before the intervention
protective sensitivity of the feet through tuning fork test
The protective sensitivity test using a tuning fork evaluates the ability to perceive vibration in specific points on the feet, typically at bony prominences. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the first session
protective sensitivity of the feet through tuning fork test
The protective sensitivity test using a tuning fork evaluates the ability to perceive vibration in specific points on the feet, typically at bony prominences. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the third session
protective sensitivity of the feet through tuning fork test
The protective sensitivity test using a tuning fork evaluates the ability to perceive vibration in specific points on the feet, typically at bony prominences. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the fifth session
protective sensitivity of the feet through tuning fork test
The protective sensitivity test using a tuning fork evaluates the ability to perceive vibration in specific points on the feet, typically at bony prominences. The outcome is classified as either the presence or absence of protective sensation.
Measured: Day after the tenth session
Fontaine Classification
primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV).
Measured: Before the intervention
Fontaine Classification
primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV).
Measured: Day after the first session
Fontaine Classification
primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV).
Measured: Day after the third session
Fontaine Classification
primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV).
Measured: Day after the fifth session
Fontaine Classification
primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV).
Measured: Day after the tenth session
Vibration Sensation
To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity
Measured: Before the intervention
Vibration Sensation
To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity
Measured: Day after the first session
Vibration Sensation
To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity
Measured: Day after the third session
Vibration Sensation
To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity
Measured: Day after the fifth session
Vibration Sensation
To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity
Measured: Day after the tenth session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start30 Jul 2024
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristianne Porta Santos Fernandes, University of Nove de Julho
- Investigators
- Raquel Agnelli Mesquita-Ferrari, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416462
- Sponsor's protocol ID
- 6.296.354
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2023
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chagas PF, Dos Santos TB, Dos Santos Trivino G, Bussadori SK, Duran CCG, Fernandes KPS, Cecatto RB, Horliana ACRT, Mesquita-Ferrari RA. Antimicrobial Photodynamic Therapy in Diabetic Amputation Ulcers: Case Series Evaluating Wound Healing Quality. Lasers Surg Med. 2025 Aug;57(6):457-465. doi: 10.1002/lsm.70037. Epub 2025 Jun 22.
PubMed 40545698
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06416462
- Acronym / sponsor ID
- 6.296.354
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds.
Detailed description
Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds. A clinical, controlled, randomized and double-blind study will be carried out. Patients will be randomized (1:1) into 2 groups: (1) experimental (n= 45) - standard care from the Polyclinic wound sector + aPDT and (2) control (n= 45) - standard care + simulation of use aPDT with equipment off). All patients will be seen three times a week, with 10 sessions of aPDT or simulation performed by the same operator. A cluster with an average radiant power of 100 mW, radiant energy per emitter of 6 J/cm² of red light (wavelength 660 nm) will be used. The research will be carried out in a Municipal Health Center in the city of Rio de Janeiro. Patients affected by neuropathic wounds of the diabetic foot, assisted by the Programmatic Care Health Coordination will be included 5.1. The initial assessment will consist of collecting data from medical records to establish the sociodemographic and clinical profile of patients affected by diabetic foot injuries.) by a researcher blinded to the interventions. This scale assesses the size of the lesion, depth, borders, detachment, type of necrotic tissue, amount of necrotic tissue, type of exudate, amount of exudate, skin color around the wound, perilesional tissue edema, perilesional tissue hardening, granulation tissue, epithelialization. As secondary outcomes: the sensitivity of the foot will be evaluated, through neurological evaluation with tuning fork and monofilament, the instrument for assessing quality of life - Diabetes-21, the Wagner Scale, the evaluation of the degree of ischemia by the Fontaine scale and Runtherford, the WiFi and Taxonomy Nursing Outcomes Classification scale that assesses skin integrity. Data from this research will be collected after approval by the ethics committee of Universidade Nove de Julho and the City Hall of Rio de Janeiro.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation of antimicroial Photodynamic therapy group | Placebo comparator | –Participants in the control group will be treated in exactly the same way as the aPDT group, however the light treatment will be simulated. The device will be placed in position, however it will be switched off. After three weeks of monitoring in the control group, the patient will be informed that they were in the placebo group and will be offered treatment with aPDT and irradiation, for ethical reasons. |
| Antimicrobial Photodynamic therapy group | Active comparator | Procedure: antimicrobial photodynamic therapyIn the experimental group (aPDT), 1% methylene blue applied with the aid of a syringe will be used as a photosensitizer (with a pre-irradiation time of 5 minutes, 6 J of red laser will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- both sexes
- chronic wounds originating from the neuropathic diabetic foot
- contaminated lesions
- total score obtained on the Bates-Jensen scale between 13 and 60
- who submits all requested exams
Key exclusion criteria (3 listed)
- wounds with etiologies that are not related to the diabetic foot
- ischemic diabetic foot who has an ankle-brachial index with a value between 0.7 and 1.3.
- glycated hemoglobin greater than 8%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antimicrobial photodynamic therapyWhen starting the research, all wounds, regardless of the study group, will be cleaned with 0.9% saline solution (SF0.9%), using a 40x12 needle and a 500ml bottle of SF0.9%, in order to maintain pressure. for equal cleaning of all wounds and a hydrofiber plate with silver was used as standard coverage. Experimental group (n=45): When starting the intervention, all services in both groups will follow the cleaning standard described previously. In the aPDT group, 1% methylene blue will be used as a photosensitizer applied with the aid of a syringe (with a pre-irradiation time of 5 minutes), 6 J of laser will be applied. | Procedure or surgery | Antimicrobial Photodynamic therapy group |
Primary outcome
Bates-Jensen Wound Assesment Tool
Time frame: Before the intervention
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen Wound Assesment Tool
Time frame: Day after the first session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen scale
Time frame: Day after the third session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen scale
Time frame: Day after the fifth session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen scale
Time frame: Day after the tenth session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5, where 1 indicates the best wound condition, and 5 represents the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with higher scores indicating worse wound conditions.
45 secondary outcomes
Diabetes twenty-one instrument
Time frame: Before the intervention
Diabetes twenty-one instrument
Time frame: Day after the first session
Diabetes twenty-one instrument
Time frame: Day after the third session
Diabetes twenty-one instrument
Time frame: Day after the fifth session
Diabetes twenty-one instrument
Time frame: Day after the tenth session
Wagner Scale
Time frame: Before the intervention
Wagner Scale
Time frame: Day after the first session
Wagner Scale
Time frame: Day after the third session
Wagner Scale
Time frame: Day after the fifth session
Wagner Scale
Time frame: Day after the tenth session
WiFi scale
Time frame: Before the intervention
WiFi scale
Time frame: Day after the first session
WiFi scale
Time frame: Day after the third session
WiFi scale
Time frame: Day after the fifth session
WiFi scale
Time frame: Day after the tenth session
Nursing Outcomes Classification Taxonomy
Time frame: Before the intervention
Nursing Outcomes Classification Taxonomy
Time frame: Day after the first session
Nursing Outcomes Classification Taxonomy
Time frame: Day after the third session
Nursing Outcomes Classification Taxonomy
Time frame: Day after the fifth session
Nursing Outcomes Classification Taxonomy
Time frame: Day after the tenth session
Runtherford Scale for ischemia evaluation
Time frame: Before the intervention
Runtherford Scale for ischemia evaluation
Time frame: Day after the first session
Runtherford Scale for ischemia evaluation
Time frame: Day after the third session
Runtherford Scale for ischemia evaluation
Time frame: Day after the fifth session
Runtherford Scale for ischemia evaluation
Time frame: Day after the tenth session
protective sensitivity of the feet through the monofilament
Time frame: Before the intervention
protective sensitivity of the feet through the monofilament
Time frame: Day after the first session
protective sensitivity of the feet through the monofilament
Time frame: Day after the third session
protective sensitivity of the feet through the monofilament
Time frame: Day after the fifth session
protective sensitivity of the feet through the monofilament
Time frame: Day after the tenth session
protective sensitivity of the feet through tuning fork test
Time frame: Before the intervention
protective sensitivity of the feet through tuning fork test
Time frame: Day after the first session
protective sensitivity of the feet through tuning fork test
Time frame: Day after the third session
protective sensitivity of the feet through tuning fork test
Time frame: Day after the fifth session
protective sensitivity of the feet through tuning fork test
Time frame: Day after the tenth session
Fontaine Classification
Time frame: Before the intervention
Fontaine Classification
Time frame: Day after the first session
Fontaine Classification
Time frame: Day after the third session
Fontaine Classification
Time frame: Day after the fifth session
Fontaine Classification
Time frame: Day after the tenth session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 40545698Chagas PF, Dos Santos TB, Dos Santos Trivino G, Bussadori SK, Duran CCG, Fernandes KPS, Cecatto RB, Horliana ACRT, Mesquita-Ferrari RA. Antimicrobial Photodynamic Therapy in Diabetic Amputation Ulcers: Case Series Evaluating Wound Healing Quality. Lasers Surg Med. 2025 Aug;57(6):457-465. doi: 10.1002/lsm.70037. Epub 2025 Jun 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Agnelli Mesquita-Ferrari, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antimicrobial photodynamic therapy in people with Diabetic Foot Ulcer, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bates-Jensen Wound Assesment Tool (time frame: Before the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06416462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.