Diabetic FootNCT06736210
The Role of Extrinsic Foot Muscles Chances in Determining the Risk of Diabetic Foot Ulcer
A study testing Muscle Elastic Properties Measurement, Muscle Oxygen Saturation (SmO2) and Plantar Pressure Analysis in people with Diabetic Foot and Diabetes Mellitus, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Many foot and lower limb disorders resulting from diabetes, such as deformity, muscle weakness, reduced range of motion, stiffness of connective tissue, amount of oxygenation, functional capacity, poor balance and coordination, can potentially be corrected or prevented with specific interventions (15). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Diabetes Mellitus
- What is being tested?
- Muscle Elastic Properties Measurement, Muscle Oxygen Saturation (SmO2) and Plantar Pressure Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 10 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willingness to participate in the study
- Absence of current or past diabetic foot ulcers
- Classification within the 0 or 1 categories of the IWGDF classification system
- Willingness to participate in the study
- Not engaging in active sports activities
- Absence of current or past foot ulcers
Who cannot join
- Presence of orthopedic, musculoskeletal, vestibular, visual, or neurological problems affecting mobility (other than DPN)
- History of prior orthopedic surgical intervention in the lower extremity
- Dementia or inability to provide consistent information
- Presence of major vascular complications (venous or arterial ulcers)
- Diagnosis of PAH (Peripheral Arterial Hypertension)
- Presence of plantar ulcers during or prior to the assessment
Show all 9Show fewer
- Inability to walk independently without pain or assistive devices
- Illiteracy
- Presence of any foot deformity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Physical Therapy and Rehabilitation Lab
Istanbul, Uskudar, 34668
About this study
Official title: The Role of Muscle Elastic Properties of Extrinsic Foot Muscles, Muscle Oxygenation and Plantar Pressure Change in Determining Diabetic Foot Ulcer Risk
Many foot and lower limb disorders resulting from diabetes, such as deformity, muscle weakness, reduced range of motion, stiffness of connective tissue, amount of oxygenation, functional capacity, poor balance and coordination, can potentially be corrected or prevented with specific interventions (15). It is important to diversify assessment methods for the development and elaboration of prevention strategies. Rapid, low-cost and detailed evaluations provide good planning of treatment. According to the International Diabetic Foot Study Group (IDFG) scale used to determine the risk of diabetic foot ulcer, it is thought that performing a plantar pressure analysis of a patient with diabetes to determine the people who do not have foot ulcers but are at risk, knowing the difference in the amount of muscle oxygenation of the muscles around the foot and ankle with healthy people and the change in muscle elastic properties will be important in terms of preventing the occurrence of diabetic foot ulcers and determining the changes of the treatments applied in the lower extremities.
Read the detailed description
Recent guidelines for the treatment and prevention of diabetic foot complications emphasize the management/control of diabetes, foot care, patient education and self-management of foot care . Other rehabilitation approaches, including exercise therapy, have recently come to the forefront in the literature within the scope of preventive treatments. Exercises have been shown to be beneficial in diabetic patients, especially in increasing nerve velocity conduction in the lower extremities . As a result of these recommendations, evaluation of the risk of diabetic foot ulceration before ulceration develops, detailed analysis of all tissues and systems expected to be affected may be solved with preventive strategies by reducing the need for treatment.
The change in plantar pressure distribution in patients with diabetes is one of the mechanisms that form the basis of the mechanisms of foot ulcer formation. Altered biomechanical structure, high intensity and repetitive diffuse pressure due to neuropathy, and insufficiency of vascular tissues caused by peripheral arterial disease directly affect the plantar pressure distribution . Determining this change before diabetic wound formation, analyzing the changing plantar pressure ratios and determining the condition in the presence of neuropathy may improve the quality of the treatment program to be created.
In the study conducted by Stephens et al. In the study conducted by Stephens et al. the plantar surface tissue of the intrinsic foot muscles oxidized following exercise interventions in patients diagnosed with diabetes mellitus.
- Conditions
- Diabetic Foot, Diabetes Mellitus
- Being tested
- Muscle Elastic Properties Measurement, Muscle Oxygen Saturation (SmO2), Plantar Pressure Analysis
- Keywords
- Diabetic Foot, Muscle Oxygenation, Muscle Elasticity
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Elastic Properties MeasurementOther
Using the MyotonPro device, the elastic properties, including stiffness, elasticity, and tone, were evaluated for the tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, and peroneus longus muscles. Measurements were performed in a controlled laboratory setting.
Muscle Oxygen Saturation (SmO2)Other
Muscle oxygenation levels were measured before and after a standardized exercise protocol using the MOXY device. The exercise protocol consisted of a light-intensity dynamic task tailored to minimize fatigue and mimic functional activity.
Plantar Pressure AnalysisOther
Plantar pressure was assessed both statically and dynamically using a pressure-mapping platform. This provided data on pressure distribution, contact times, and high-pressure areas across the foot during various conditions.
| Study group | Role | What they receive |
|---|---|---|
| Health Control Group | Experimental | The healthy control group consisted of 10 participants with no history of foot or ankle injuries or systemic diseases, ensuring a baseline for comparison. Assessments included isokinetic testing for plantar flexor (PF) and dorsiflexor (DF) muscle strength and endurance at angular velocities of 30°/s and 120°/s, respectively. Additionally, functional evaluations such as the physical performance (heel-rise) test and patient-reported outcome measures (AOFAS and FAOS scores) were conducted. These evaluations provided a comprehensive understanding of muscle performance and functional status in healthy individuals, serving as a reference point for interpreting deviations observed in the Lisfranc injury group. Receives: Other: Muscle Elastic Properties Measurement; Other: Muscle Oxygen Saturation (SmO2); Other: Plantar Pressure Analysis |
| IWDGF-0 | Experimental | The IWGDF 0 group included 10 patients classified as having no immediate risk for diabetic foot ulcers. Assessments focused on evaluating the biomechanical and functional parameters of extrinsic foot muscles. Muscle elasticity and dynamic stiffness were measured using the MyotonPro device, while muscle oxygenation levels (SmO2) were recorded pre- and post-exercise using the MOXY device. Plantar pressure analysis was performed under both static and dynamic conditions to identify subtle variations in pressure distribution and foot biomechanics. These evaluations aimed to detect early indicators of potential foot complications, even in patients without apparent risk, providing critical data for preventive strategies. Receives: Other: Muscle Elastic Properties Measurement; Other: Muscle Oxygen Saturation (SmO2); Other: Plantar Pressure Analysis |
| IWDGF-1 | Experimental | The IWGDF 1 group comprised 10 patients identified as having low risk for diabetic foot ulcers. Comprehensive assessments were conducted to evaluate the biomechanical and functional properties of their extrinsic foot muscles. Elasticity and dynamic stiffness of the tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, and peroneus longus muscles were measured using the MyotonPro device. Muscle oxygenation levels (SmO2) were monitored pre- and post-exercise using the MOXY device to determine oxygen utilization and recovery capacity. Additionally, plantar pressure was analyzed under static and dynamic conditions to assess changes in pressure distribution and foot biomechanics. These detailed evaluations highlighted early biomechanical and functional changes, emphasizing the importance of targeted interventions in this low-risk group to prevent progression to higher risk categories. Receives: Other: Muscle Elastic Properties Measurement; Other: Muscle Oxygen Saturation (SmO2); Other: Plantar Pressure Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Elastic Properties
Stiffness, elasticity, and tone of the tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, and peroneus longus muscles measured using the MyotonPro device.
Key Metrics: Differences in muscle stiffness, tone, and elasticity between groups.
Measured: Measured within a 1-month period.
Secondary outcomes (2)
Muscle Oxygenation (SmO2)
Changes in local oxygen saturation (SmO2) levels of the targeted muscles, measured pre- and post-exercise using the MOXY device.
Comparison of SmO2 levels between IWGDF 0, IWGDF 1, and healthy control groups. Key Metrics: Reduction in SmO2 levels and recovery trends post-exercise
Measured: Measured within a 1-month period.
Plantar Pressure Parameters
Static and dynamic plantar pressure analysis to identify high-pressure regions and foot loading patterns.
Key Metrics:
Average plantar pressure values in midfoot and forefoot regions. Contact times and pressure distribution in dynamic gait analysis.
Measured: Measured within a 1-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Nov 2024
- Primary completion30 Nov 2024
- Study completion10 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 FootStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ilez, Istanbul Saglik Bilimleri University
- Investigators
- Defne KAYA UTLU, PhD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736210
- Sponsor's protocol ID
- SBU-FTR-AI-01
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.
PubMed 37395769
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Muscle Elastic Properties of Extrinsic Foot Muscles, Muscle Oxygenation and Plantar Pressure Change in Determining Diabetic Foot Ulcer Risk
- ClinicalTrials.gov ID
- NCT06736210
- Acronym / sponsor ID
- SBU-FTR-AI-01
- Conditions
- Diabetic Foot, Diabetes Mellitus
- Keywords
- Diabetic Foot, Muscle Oxygenation, Muscle Elasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 16 Dec 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.
Many foot and lower limb disorders resulting from diabetes, such as deformity, muscle weakness, reduced range of motion, stiffness of connective tissue, amount of oxygenation, functional capacity, poor balance and coordination, can potentially be corrected or prevented with specific interventions (15). It is important to diversify assessment methods for the development and elaboration of prevention strategies. Rapid, low-cost and detailed evaluations provide good planning of treatment. According to the International Diabetic Foot Study Group (IDFG) scale used to determine the risk of diabetic foot ulcer, it is thought that performing a plantar pressure analysis of a patient with diabetes to determine the people who do not have foot ulcers but are at risk, knowing the difference in the amount of muscle oxygenation of the muscles around the foot and ankle with healthy people and the change in muscle elastic properties will be important in terms of preventing the occurrence of diabetic foot ulcers and determining the changes of the treatments applied in the lower extremities.
Detailed description
Recent guidelines for the treatment and prevention of diabetic foot complications emphasize the management/control of diabetes, foot care, patient education and self-management of foot care . Other rehabilitation approaches, including exercise therapy, have recently come to the forefront in the literature within the scope of preventive treatments. Exercises have been shown to be beneficial in diabetic patients, especially in increasing nerve velocity conduction in the lower extremities . As a result of these recommendations, evaluation of the risk of diabetic foot ulceration before ulceration develops, detailed analysis of all tissues and systems expected to be affected may be solved with preventive strategies by reducing the need for treatment.
The change in plantar pressure distribution in patients with diabetes is one of the mechanisms that form the basis of the mechanisms of foot ulcer formation. Altered biomechanical structure, high intensity and repetitive diffuse pressure due to neuropathy, and insufficiency of vascular tissues caused by peripheral arterial disease directly affect the plantar pressure distribution . Determining this change before diabetic wound formation, analyzing the changing plantar pressure ratios and determining the condition in the presence of neuropathy may improve the quality of the treatment program to be created.
In the study conducted by Stephens et al. In the study conducted by Stephens et al. the plantar surface tissue of the intrinsic foot muscles oxidized following exercise interventions in patients diagnosed with diabetes mellitus.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Control Group | Experimental | Other: Muscle Elastic Properties Measurement, Other: Muscle Oxygen Saturation (SmO2), Other: Plantar Pressure AnalysisThe healthy control group consisted of 10 participants with no history of foot or ankle injuries or systemic diseases, ensuring a baseline for comparison. Assessments included isokinetic testing for plantar flexor (PF) and dorsiflexor (DF) muscle strength and endurance at angular velocities of 30°/s and 120°/s, respectively. Additionally, functional evaluations such as the physical performance (heel-rise) test and patient-reported outcome measures (AOFAS and FAOS scores) were conducted. These evaluations provided a comprehensive understanding of muscle performance and functional status in healthy individuals, serving as a reference point for interpreting deviations observed in the Lisfranc injury group. |
| IWDGF-0 | Experimental | Other: Muscle Elastic Properties Measurement, Other: Muscle Oxygen Saturation (SmO2), Other: Plantar Pressure AnalysisThe IWGDF 0 group included 10 patients classified as having no immediate risk for diabetic foot ulcers. Assessments focused on evaluating the biomechanical and functional parameters of extrinsic foot muscles. Muscle elasticity and dynamic stiffness were measured using the MyotonPro device, while muscle oxygenation levels (SmO2) were recorded pre- and post-exercise using the MOXY device. Plantar pressure analysis was performed under both static and dynamic conditions to identify subtle variations in pressure distribution and foot biomechanics. These evaluations aimed to detect early indicators of potential foot complications, even in patients without apparent risk, providing critical data for preventive strategies. |
| IWDGF-1 | Experimental | Other: Muscle Elastic Properties Measurement, Other: Muscle Oxygen Saturation (SmO2), Other: Plantar Pressure AnalysisThe IWGDF 1 group comprised 10 patients identified as having low risk for diabetic foot ulcers. Comprehensive assessments were conducted to evaluate the biomechanical and functional properties of their extrinsic foot muscles. Elasticity and dynamic stiffness of the tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, and peroneus longus muscles were measured using the MyotonPro device. Muscle oxygenation levels (SmO2) were monitored pre- and post-exercise using the MOXY device to determine oxygen utilization and recovery capacity. Additionally, plantar pressure was analyzed under static and dynamic conditions to assess changes in pressure distribution and foot biomechanics. These detailed evaluations highlighted early biomechanical and functional changes, emphasizing the importance of targeted interventions in this low-risk group to prevent progression to higher risk categories. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Willingness to participate in the study
- Absence of current or past diabetic foot ulcers
- Classification within the 0 or 1 categories of the IWGDF classification system
- Willingness to participate in the study
- Not engaging in active sports activities
Key exclusion criteria (9 listed)
- Presence of orthopedic, musculoskeletal, vestibular, visual, or neurological problems affecting mobility (other than DPN)
- History of prior orthopedic surgical intervention in the lower extremity
- Dementia or inability to provide consistent information
- Presence of major vascular complications (venous or arterial ulcers)
- Diagnosis of PAH (Peripheral Arterial Hypertension)
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 |
|---|---|---|
| Muscle Elastic Properties MeasurementUsing the MyotonPro device, the elastic properties, including stiffness, elasticity, and tone, were evaluated for the tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, and peroneus longus muscles. Measurements were performed in a controlled laboratory setting. | Other | Health Control Group, IWDGF-0, IWDGF-1 |
| Muscle Oxygen Saturation (SmO2)Muscle oxygenation levels were measured before and after a standardized exercise protocol using the MOXY device. The exercise protocol consisted of a light-intensity dynamic task tailored to minimize fatigue and mimic functional activity. | Other | Health Control Group, IWDGF-0, IWDGF-1 |
| Plantar Pressure AnalysisPlantar pressure was assessed both statically and dynamically using a pressure-mapping platform. This provided data on pressure distribution, contact times, and high-pressure areas across the foot during various conditions. | Other | Health Control Group, IWDGF-0, IWDGF-1 |
Primary outcome
Muscle Elastic Properties
Time frame: Measured within a 1-month period.
Stiffness, elasticity, and tone of the tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, and peroneus longus muscles measured using the MyotonPro device. Key Metrics: Differences in muscle stiffness, tone, and elasticity between groups.
2 secondary outcomes
Muscle Oxygenation (SmO2)
Time frame: Measured within a 1-month period.
Plantar Pressure Parameters
Time frame: Measured within a 1-month period.
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 16 Dec 2024.
- Background: PubMed 37395769Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.
- Individual participant dataSharing planned: Undecided
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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.
Defne KAYA UTLU, PhD study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Elastic Properties Measurement, Muscle Oxygen Saturation (SmO2) and Plantar Pressure Analysis in people with Diabetic Foot and Diabetes Mellitus, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 6 inclusion and 9 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 16 Dec 2024. 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 Turkey (Türkiye). 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. 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?
Muscle Elastic Properties (time frame: Measured within a 1-month period.). 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 NCT06736210, 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 16 Dec 2024.