The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Ulcer recurrence
研究概览
简要总结
The main purpose of this study is to assess the efficacy of flexor tenotomy on the prevention of recurrence of toe ulcers in people with diabetes and a history of toe ulceration. Additionally, the investigators aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, bare-foot plantar pressure during walking and quality of life before and after the intervention and compare between study groups.
详细描述
Foot ulcers are a frequent problem in patients with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformity is commonly seen in patients with diabetes. These deformities increase the risk of ulcer development specifically at the (apex of) the toe. Tenotomy of the tendon of the flexor muscles of the toes (tendon tenotomy) can be used to treat the consequences of claw/hammer toe deformity with the goal to prevent ulcer recurrence. For indication and assessment of outcomes of flexor tenotomy, weight-bearing CT and dynamic barefoot plantar pressure measurement can be used. This mono-center investigator blinded randomized controlled trial will compare the flexor tenotomy with usual care (including orthoses and shoe offloading). The effect on ulcer recurrence, toe joint angles, barefoot plantar pressure and quality of life will be assessed and compared between the intervention and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A minimum age of 18 years
- •Sufficient understanding of Dutch/English language
- •Capable of filling out informed consent
- •Peripheral polyneuropathy
- •Diabetes mellitus type 1 or 2
- •A minimum of one claw/hammer toe
- •A documented history of diabetic ulcers underneath the toe apex in the past 5 years
排除标准
- •No written informed consent
- •Not meeting the inclusion criteria
- •Open ulcers on the toes
- •Previous participation in the study
- •Pregnant women
- •Concomitant participation in a study in which the patient is exposed to X-rays
结局指标
主要结局
Ulcer recurrence
时间窗: 24 months
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads
次要结局
- DIPJ, PIPJ and MTPJ angles(Baseline, 6 and 12 months)
- Barefoot pressure pattern(Baseline, 6 and 12 months)
- Patient-reported outcome measures: EuroQol's EQ-5D-5L(Baseline, 6, 12 and 24 months)
- Patient-reported outcome measures: SF-36(Baseline, 6, 12 and 24 months)
- Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years(24 months)
研究者
Marieke Mens
Coördinating investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)