Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission: a Three Arm Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Recurrence rate
研究概览
简要总结
The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). The literature suggests to clinically check the patients in a 4-12 weeks basis, despite this, this recommendation is based in expert opinions.
The main question it aims to answer is:
- Does different revision times could affect the reulceration rate in persons with diabetes in remission. Different revision time will be 2 weeks, 4 weeks and 6 weeks.
详细描述
The planned RCT try to elucidate if there exist any difference in ulcer recurrence between different revisions times in persons with a previous healed diabetic foot ulcer and currently under remission.
There will exist three different groups for analyses after randomization:
- Group 1: patients revised every fourweeks.
- Group 2: patients revised every eightweeks.
- Group 3: patients revised every twelveweeks.
Main outcome measure will include:
- Recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the IWGDF guidelines. Recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level.
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
- None
盲法说明
No masking is possible to be performed in the planned RCT due to the nature of the intervention (time dependent).
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
- •Patients aged 18 years or older.
- •Type 1 or type 2 diabetes.
- •Presence of diabetic polyneuropathy (diagnosed as an inability to sense the pressure of a 10-g Semmes-Weinstein monofilament at three plantar foot sites and/or a vibration perception threshold >25 V, as assessed using a bio-tensiometer.
- •Patients classified as high-risk patients (risk 3 patients according to the IWGDF guidance). Previous healed diabetic foot ulcer.
排除标准
- •Active diabetic foot ulcers during inclusion.
- •Active Charcot foot process.
- •Conditions other than diabetes also associated with foot ulcers were excluded from the study as well.
结局指标
主要结局
Recurrence rate
时间窗: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Defined as as break in the foot skin at the epidermis and part of the dermis level.
次要结局
- Minor amputation rate(From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.)
- Minor lesion rate(From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.)
研究者
Mateo López-Moral, DPM, PhD
Prof. Dr
Universidad Complutense de Madrid