跳至主要内容
临床试验/NCT06736210
NCT06736210已完成不适用

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

Istanbul Saglik Bilimleri University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Muscle Elastic Properties

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Muscle Elastic Properties

时间窗: 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.

次要结局

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

研究者

发起方
Istanbul Saglik Bilimleri University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Ilez

Research Assistant

Istanbul Saglik Bilimleri University

研究点 (2)

Loading locations...

相似试验