The Role of Extrinsic Foot Muscles Chances in Determining the Risk of Diabetic Foot Ulcer

Not Applicable

Completed

• Conditions: Diabetic Foot; Diabetes Mellitus

• Registration Number: NCT06736210
• Lead Sponsor: Istanbul Saglik Bilimleri University

Brief 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). 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 Timeline

• Study Start: 2024-11-01
• Primary Completion: 2024-11-30
• Status Verified: 2024-12
• Study Completion: 2024-12-10
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Muscle Elastic Properties	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.

Secondary Outcome Measures

Name	Time	Method
Muscle Oxygenation (SmO2)	Measured within a 1-month period.	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
Plantar Pressure Parameters	Measured within a 1-month period.	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.

Trial Locations

Locations (1)

University of Health Sciences Physical Therapy and Rehabilitation Lab; 🇹🇷 İ̇stanbul, Uskudar, Turkey