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

NCT06736210 | Completed

• 1 other identifier: SBU-FTR-AI-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Diabetes Mellitus

Keywords

Diabetic Foot; Muscle Oxygenation; Muscle Elasticity

Outcome Measures

Primary Outcomes (1)

• 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 within a 1-month period.

Secondary Outcomes (2)

• Muscle Oxygenation (SmO2)

  Measured within a 1-month period.

• Plantar Pressure Parameters

  Measured within a 1-month period.

Other Outcomes (1)

• Functional Integration

  Measured within a 1-month period.

Study Arms (3)

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.

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.

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.

Other: Muscle Elastic Properties Measurement; Other: Muscle Oxygen Saturation (SmO2); Other: Plantar Pressure Analysis

Interventions

Muscle Elastic Properties Measurement OTHER

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.

Health Control Group; IWDGF-0; IWDGF-1

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.

Health Control Group; IWDGF-0; IWDGF-1

Plantar Pressure Analysis OTHER

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.

Health Control Group; IWDGF-0; IWDGF-1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

University of Health Sciences Physical Therapy and Rehabilitation Lab

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37395769 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Defne KAYA UTLU, PhD

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: November 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 10, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

TU (1)