Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
研究概览
简要总结
Diabetic foot complications are a common and costly problem. Excessive plantar pressures due to foot deformities and/or limited ankle dorsiflexion, especially in the presence of peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers. Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot ulcers.
Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology) was effective in treating subjects with chronic heel pain and Achilles tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to perform more effective stretching exercises and may prevent recurrence of diabetic foot ulcers.
The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk subjects with a history of diabetic foot ulcer.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 21 to 65, inclusive
- •Diabetes, either type 1 or 2
- •Ankle equinus (< 0º passive ankle dorsiflexion with knee extended)
- •Forefoot plantar hyperkeratosis (callus)
- •Able to walk independently without the use of walking aids (cane, crutches, or walker)
- •Able to understand the information in the informed consent form and willing and able to comply with study-related procedures
排除标准
- •Previous history of ankle-foot surgery or amputation
- •no active lower extremity skin ulcers
- •Peripheral vascular disease (non-palpable pedal pulses or ankle brachial index <0.8)
- •Not willing or able to make required visits
- •Nursing or pregnant
- •Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel, including discontinuation of icing, NSAIDs and natural anti-inflammatory agents (such as Arnica)
结局指标
主要结局
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
时间窗: at baseline visit and at 4 weeks
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.
时间窗: at baseline visit and 4 weeks
次要结局
- Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.(at 1 month and at 3 months)
- Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months.(at 1 month and at 3 months)