Clinical trial NCT06736210: The Role of Extrinsic Foot Muscles Chances in Determining the Risk of Diabetic Foot Ulcer
Official title: The Role of Muscle Elastic Properties of Extrinsic Foot Muscles, Muscle Oxygenation and Plantar Pressure Change in Determining Diabetic Foot Ulcer Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Diabetes Mellitus
Keywords: Diabetic Foot
Muscle Oxygenation
Muscle Elasticity
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria for Patients with Diabetes:

* 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

Inclusion Criteria for Sedentary Healthy Participants:

* Willingness to participate in the study
* Not engaging in active sports activities
* Absence of current or past foot ulcers

Exclusion Criteria for all group:

* 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
* Inability to walk independently without pain or assistive devices
* Illiteracy
* Presence of any foot deformity

Primary outcomes:
measure: Muscle Elastic Properties
timeFrame: Measured within a 1-month period.
Secondary outcomes:
measure: Muscle Oxygenation (SmO2)
timeFrame: Measured within a 1-month period.
measure: Plantar Pressure Parameters
timeFrame: Measured within a 1-month period.
Other outcomes:
measure: Functional Integration
timeFrame: Measured within a 1-month period.
Locations:
city: İ̇stanbul
country: Turkey
facility: University of Health Sciences Physical Therapy and Rehabilitation Lab
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Defne KAYA UTLU, PhD
role: STUDY_DIRECTOR
References:
citation: 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.