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Completed
NCT05422846
Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds
Conditions: Diabetic Foot Ulcer, Wound
Sex: All
Ages: 35 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 51
Sponsor: Harran University
Location: Harran Unıversıty Sanliurfa Şanlıurfa
Summary
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.
Eligibility Criteria
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 kg/m²).
* Individuals with proliferative diabetic retinopathy.
Source: ClinicalTrials.gov (NCT05422846). StuddyBuddy aggregates publicly available trial information.