Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds

Harran University51 enrolled

Overview

Diabetic foot ulcers are a common complication of diabetes mellitus and are associated with delayed wound healing, impaired quality of life, and an increased risk of lower extremity amputation. Although regular exercise is recommended for people with diabetes, evidence regarding the safety and effectiveness of structured exercise therapy in individuals with diabetic foot ulcers remains limited. This randomized controlled trial aims to evaluate the effects of two different exercise interventions on wound healing and quality of life in adults with diabetic foot ulcers. Participants are randomly assigned to one of three groups: a structured exercise group, an aerobic exercise group, or a standard care control group. The intervention lasts 12 weeks, with supervised exercise sessions twice weekly. Outcomes, including ulcer surface area, ulcer depth, quality of life, sleep quality, and kinesiophobia, are assessed at baseline, Week 4, Week 8, and Week 12.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer Wound

Interventions

exercise protocolOTHER

The protocol exercise group will be provided with the necessary approaches for diabetic foot ulcer care and exercises suitable for the physical condition of the wound and the patient, in addition to diaphragmatic breathing exercises. This group will also work with a physiotherapist twice a week.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults diagnosed with type 2 diabetes mellitus and presenting with a diabetic foot ulcer. * Presence of a Wagner grade 1 or grade 2 diabetic foot ulcer. * Absence of severe musculoskeletal, cardiovascular, neurological, or other systemic diseases that could interfere with participation in the study or affect the study outcomes. * Ability to communicate effectively and comply with study procedures. * Receiving the same standard diabetic foot wound care protocol throughout the study. * Not receiving any additional treatment or intervention that could influence wound healing during the study period. Exclusion Criteria: * Individuals with a diagnosed psychiatric disorder. * Individuals who have received physiotherapy treatment within the previous 3 months. * Individuals with an acute infection. * Individuals with a toe pressure \<40 mmHg. * Individuals diagnosed with Charcot foot and/or osteomyelitis. * Individuals with venous leg ulcers. * Individuals with morbid obesity (body mass index \[BMI\] \>40 kg/m²). * Individuals with proliferative diabetic retinopathy.

Outcomes

Primary Outcomes

ulcer area (mm²)

Ulcer surface area measured using ImageJ software.

Time frame: Baseline, Week 4, Week 8, and Week 12

ulcer depth (mm)

Ulcer depth measured with sterile wound stick

Time frame: Baseline and Week 12

Secondary Outcomes

quality of life score

Ferrans and Powers Quality of Life Index - Diabetes Version

Time frame: Baseline and Week 12

sleep quality score

investigating the sleep quality of patients with the Pittsburgh sleep quality index

Time frame: initial assessment - 12th week