Soft Tissue InjuriesPhase 1/2NCT04361773
Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries
A Phase 1/2 study testing Photobiomodulation in people with Soft Tissue Injuries, run by University of Nove de Julho.
Trial summary
Soft tissue injuries are directly related to the energy of the trauma and its repair is the main factor for bone healing and the recovery of the function of the affected limb. Photobiomodulation (PBM) is indicated as an adjuvant treatment to accelerate wound healing, however, there is still a lack of evidence… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2020to 30 Dec 2021
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult individuals of both sexes, aged between 18 and 60 years;
- Interned in the Orthopedics and Infirmary Emergency Room of the Surgical Clinic of Conjunto Hospitalar do Mandaqui;
- Victims of high-energy trauma in the lower limbs with sufficient soft tissue injury to make primary closure unfeasible or definitive treatment of injuries in the initial care associated with tibial fracture.
Who cannot join
- Diagnosis of chronic systemic diseases (renal failure, diabetes mellitus, hypertension, peripheral vascular insufficiency);
- Allergy to cefazolin and gentamicin;
- Uncontrollable active bleeding;
- Occlusive arteriopathies;
- Compartmental syndrome;
- Necrosis in the area of neurovascular injury with sensory deficit at the injury site;
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- History of previous surgeries on the affected limb;
- Local or systemic changes that contraindicate surgical intervention or hinder the postoperative period;
- Smoking;
- Photo sensitivity history;
- Neurological and psychiatric disorders;
- Use of anti-inflammatory drugs in the last 15 days prior to the trauma;
- Pregnant women.
About this study
Official title: Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries: Study Protocol for a Double-Blind, Randomized, Controlled Trial
Soft tissue injuries are directly related to the energy of the trauma and its repair is the main factor for bone healing and the recovery of the function of the affected limb. Photobiomodulation (PBM) is indicated as an adjuvant treatment to accelerate wound healing, however, there is still a lack of evidence regarding its effect on traumatic soft tissue injuries. This project aims to evaluate the effects of the application of PBM in the resolution of complex soft tissue injuries of traumatic origin associated with tibial fractures. 84 adult individuals, aged between 18 and 60 years, hospitalized with tibial fractures awaiting resolution of soft tissue injuries will be included to undergo definitive surgery. The subjects will be randomized in two groups: PBM (treated with a device with 144 LED emitting diodes at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes) and Sham (simulation of the LED application, with a device with characteristics identical to that of the PBM group, for the same period of time). Subjects will be treated daily until release for surgery. The primary outcome will be the assessment of the wound healing process using the BATES-JENSEN scale. Secondary outcomes will be: pain intensity; consumption of analgesic drugs; serum evolution of inflammatory markers C-reactive protein and creatine kinase, measurement of the lesion area, time needed for release for definitive surgery, presence of infection, and the cost-effectiveness of PBM. The evaluations will be carried out before the beginning of the intervention and daily until the participant is considered ready for surgery (which will be considered the end of the experimental period). Data will be analyzed statistically considering a significance level of 5%.
- Conditions
- Soft Tissue Injuries
- Being tested
- Photobiomodulation, Sham Photobiomodulation
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationRadiation
Treatment with a device with 144 light emitting diodes (LEDs) at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes.
Sham PhotobiomodulationOther
Simulation of the LED application, with a device with external characteristics identical to that of the PBM group, for the same period of time.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Active comparator | In this group, PBM will be applied daily using LED devices until the lesion presents healthy granulation tissue, absence of necrosis and purulent secretion and, therefore, is suitable for primary closure, closure by flap or graft or for healing by second intention. At this point, the protocol will be finalized. Receives: Radiation: Photobiomodulation |
| Sham group | Sham comparator | Sham group participants will receive the application of the disconnected device, for the same period. The characteristic sound of the device will be activated by means of recording. Receives: Other: Sham Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the wound healing process using the BATES-JENSEN scale
Evaluation of the healing process of soft tissue injuries in lower limbs associated with tibial fractures caused by high-energy trauma using the variation in the Bates Jensen Wound Assessment Tool scale score. The current version of BWAT contains 13 items that measure size, depth, borders, detachment, type and amount of necrotic tissue, type and amount of exudate, edema and hardening of the peripheral tissue, skin color around the wound, granulation tissue and epithelialization. The measurement scale is of the Likert type, with five points, where 1 indicates the best condition of the wound and 5, the worst condition. The total score is obtained with the sum of all items and can vary from 13 to 65 points, with the highest scores indicating the worst wound conditions. The items size, depth, edges and detachment should be scored as zero when the lesions are healed. The instrument contains two additional items - location and shape - that are not part of the total score.
Measured: Baseline and through study completion, an average of 1 month.
Secondary outcomes (8)
Change in Pain Intensity Through VAS
Pain will be assessed by field researchers by applying the visual analogue pain scale (VAS). This scale is represented by a 10 cm line, with the phrases "no pain" and "unbearable pain" at its ends.
Measured: Baseline and through study completion, an average of 1 month.
Consumption of painkillers
The type, dosage and frequency of analgesic consumption will be checked and recorded daily during the medical visit by the field team responsible for the daily medical visit. The results will be passed on to the main researcher for storage, tabulation and interpretation.
Measured: Baseline and through study completion, an average of 1 month.
Change in serum evolution of inflammatory markers
For laboratory evaluation of the evolution of the inflammatory process and muscle damage, the following tests will be collected: C-reactive protein (CRP), Creatinophosphokinase (CPK), serum urea, creatinine, blood count and coagulogram. These exams will be collected at the time of admission, every three days and when the soft parts are resolved.
Measured: Baseline, every three days and through study completion, an average of 1 month.
Change in Lesion Area Measurement
The wounds will be photographed along with a cut of graph paper using the camera of the iPhone 8 mobile device, to allow the calibration of the measurement application. The photos will be taken by the doctors who will visit the patient daily at the patient's bed and pass them on to the main researcher. The images will be stored and later evaluated with the aid of the Image J® application, a public domain Java image processor and analyzer, developed by Wayne Rasband of the Research Services Branch, National Institute of Mental Health, Bethesda, Maryland.
Measured: Baseline and through study completion, an average of 1 month.
Time needed for liberation for definitive surgery
Each lesion will be considered solved when it presents healthy granulation tissue, without necrosis or purulent secretion and is, therefore, suitable for primary closure, flap or graft closure or apt to choose healing by second intention. At this point, the protocol will be finalized and this data will be added to the study participant's medical record.
Measured: Baseline and through study completion, an average of 1 month.
Presence of Infection
Field researchers will collect information regarding the patient's temperature, blood pressure and heart rate every 24 hours. In addition, the wound will be evaluated for the presence of secretion, necrosis, odor and color. If the wound shows signs of infection (purulent secretion, foul odor, areas of superficial or deep necrosis, accompanied or not by systemic signs such as fever, a fall in general condition, lack of appetite), surgical cleaning of the wound will be indicated, and at this moment, collections of samples for culture and photographs before and after surgical debridement will be carried out by field researchers. The patient will be excluded from the study.
Measured: Baseline and through study completion, an average of 1 month.
Cost effectiveness of Photobiomodulation
The cost-effectiveness establishes whether or not a treatment should be implemented as a therapeutic measure, being calculated by the difference between the cost of two interventions proposed as treatment divided by the difference between its consequences. For the evaluation of the cost-effectiveness of photobiomodulation, the "reduction in the score of the Bates Jensen scale" will be considered as the outcome.
Measured: Baseline and through study completion, an average of 1 month.
Change in Peripheral Perfusion through Clinical Evaluation
The peripheral perfusion of the affected limb will also be evaluated clinically by two doctors, through palpation of the distal pulses (pedicle and posterior tibial), pain and passive extension of the fingers (to clinically assess the occurrence of compartment syndrome) capillary filling time, limb, granulation of the wound, occurrence of superficial or deep necrosis. In case of vascular involvement of the limb, joint assessment with the vascular surgery service will be requested and the case will be excluded from the study.
Measured: Baseline and through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start30 May 2020 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361773
- Sponsor's protocol ID
- TraumaSoftTissue
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries: Study Protocol for a Double-Blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04361773
- Acronym / sponsor ID
- TraumaSoftTissue
- Conditions
- Soft Tissue Injuries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 May 2020 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 24 Apr 2020 (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.
Soft tissue injuries are directly related to the energy of the trauma and its repair is the main factor for bone healing and the recovery of the function of the affected limb. Photobiomodulation (PBM) is indicated as an adjuvant treatment to accelerate wound healing, however, there is still a lack of evidence regarding its effect on traumatic soft tissue injuries. This project aims to evaluate the effects of the application of PBM in the resolution of complex soft tissue injuries of traumatic origin associated with tibial fractures. 84 adult individuals, aged between 18 and 60 years, hospitalized with tibial fractures awaiting resolution of soft tissue injuries will be included to undergo definitive surgery. The subjects will be randomized in two groups: PBM (treated with a device with 144 LED emitting diodes at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes) and Sham (simulation of the LED application, with a device with characteristics identical to that of the PBM group, for the same period of time). Subjects will be treated daily until release for surgery. The primary outcome will be the assessment of the wound healing process using the BATES-JENSEN scale. Secondary outcomes will be: pain intensity; consumption of analgesic drugs; serum evolution of inflammatory markers C-reactive protein and creatine kinase, measurement of the lesion area, time needed for release for definitive surgery, presence of infection, and the cost-effectiveness of PBM. The evaluations will be carried out before the beginning of the intervention and daily until the participant is considered ready for surgery (which will be considered the end of the experimental period). Data will be analyzed statistically considering a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Active comparator | Radiation: PhotobiomodulationIn this group, PBM will be applied daily using LED devices until the lesion presents healthy granulation tissue, absence of necrosis and purulent secretion and, therefore, is suitable for primary closure, closure by flap or graft or for healing by second intention. At this point, the protocol will be finalized. |
| Sham group | Sham comparator | Other: Sham PhotobiomodulationSham group participants will receive the application of the disconnected device, for the same period. The characteristic sound of the device will be activated by means of recording. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult individuals of both sexes, aged between 18 and 60 years;
- Interned in the Orthopedics and Infirmary Emergency Room of the Surgical Clinic of Conjunto Hospitalar do Mandaqui;
- Victims of high-energy trauma in the lower limbs with sufficient soft tissue injury to make primary closure unfeasible or definitive treatment of injuries in the initial care associated with tibial fracture.
Key exclusion criteria (13 listed)
- Diagnosis of chronic systemic diseases (renal failure, diabetes mellitus, hypertension, peripheral vascular insufficiency);
- Allergy to cefazolin and gentamicin;
- Uncontrollable active bleeding;
- Occlusive arteriopathies;
- Compartmental syndrome;
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 |
|---|---|---|
| PhotobiomodulationTreatment with a device with 144 light emitting diodes (LEDs) at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes. | Radiation | Photobiomodulation group |
| Sham PhotobiomodulationSimulation of the LED application, with a device with external characteristics identical to that of the PBM group, for the same period of time. | Other | Sham group |
Primary outcome
Change of the wound healing process using the BATES-JENSEN scale
Time frame: Baseline and through study completion, an average of 1 month.
Evaluation of the healing process of soft tissue injuries in lower limbs associated with tibial fractures caused by high-energy trauma using the variation in the Bates Jensen Wound Assessment Tool scale score. The current version of BWAT contains 13 items that measure size, depth, borders, detachment, type and amount of necrotic tissue, type and amount of exudate, edema and hardening of the peripheral tissue, skin color around the wound, granulation tissue and epithelialization. The measurement scale is of the Likert type, with five points, where 1 indicates the best condition of the wound and 5, the worst condition. The total score is obtained with the sum of all items and can vary from 13 to 65 points, with the highest scores indicating the worst wound conditions. The items size, depth, edges and detachment should be scored as zero when the lesions are healed. The instrument contains two additional items - location and shape - that are not part of the total score.
8 secondary outcomes
Change in Pain Intensity Through VAS
Time frame: Baseline and through study completion, an average of 1 month.
Consumption of painkillers
Time frame: Baseline and through study completion, an average of 1 month.
Change in serum evolution of inflammatory markers
Time frame: Baseline, every three days and through study completion, an average of 1 month.
Change in Lesion Area Measurement
Time frame: Baseline and through study completion, an average of 1 month.
Time needed for liberation for definitive surgery
Time frame: Baseline and through study completion, an average of 1 month.
Presence of Infection
Time frame: Baseline and through study completion, an average of 1 month.
Cost effectiveness of Photobiomodulation
Time frame: Baseline and through study completion, an average of 1 month.
Change in Peripheral Perfusion through Clinical Evaluation
Time frame: Baseline and through study completion, an average of 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Photobiomodulation in people with Soft Tissue Injuries, run by University of Nove de Julho.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change of the wound healing process using the BATES-JENSEN scale (time frame: Baseline and through study completion, an average of 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2020.