Investigation of the Effect of Different Exercise Training on Wound Healing ın Patients With Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- ulcer area (mm²)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
control group
Participants received standard diabetic foot ulcer care according to institutional practice without structured exercise therapy.
干预措施: standard treatment (Other)
exercise protocol group
Participants received a supervised structured exercise programme tailored to ulcer status and individual physical capacity twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.
干预措施: exercise protocol (Other)
aerobic exercise group
Participants received supervised aerobic exercise using a bicycle ergometer twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.
干预措施: aerobic exercise (Other)
结局指标
主要结局
ulcer area (mm²)
时间窗: Baseline, Week 4, Week 8, and Week 12
Ulcer surface area measured using ImageJ software.
ulcer depth (mm)
时间窗: Baseline and Week 12
Ulcer depth measured with sterile wound stick
次要结局
- quality of life score(Baseline and Week 12)
- sleep quality score(initial assessment - 12th week)
研究者
Fatih Enzin
Principal Investigator
Harran University