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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06736210
Enrollment
30
Registered
2024-12-16
Start date
2024-11-01
Completion date
2024-12-10
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot, Diabetes Mellitus

Keywords

Diabetic Foot, Muscle Oxygenation, Muscle Elasticity

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.

Interventions

OTHERMuscle 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.

OTHERMuscle 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.

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.

Sponsors

Istanbul Saglik Bilimleri University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle Elastic PropertiesMeasured 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

MeasureTime frameDescription
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 ParametersMeasured 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.

Other

MeasureTime frameDescription
Functional IntegrationMeasured within a 1-month period.Evaluation of the relationship between plantar pressure patterns and muscle biomechanical properties across all groups.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026