NCT06736210

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

The Role of Muscle Elastic Properties of Extrinsic Foot Muscles, Muscle Oxygenation and Plantar Pressure Change in Determining Diabetic Foot Ulcer Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Istanbul Saglik Bilimleri University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Foot
• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Muscle Elastic Properties Measurement	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.
OTHER	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	Plantar Pressure Analysis	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2024-11-30
• Completion: 2024-12-10
• First posted: 2024-12-16
• Last updated: 2024-12-16

Locations

1 site across 1 country: Turkey (Türkiye)