Clinical Efficacy of a 3D Foot Scanner App for the Fitting of Therapeutic Footwear in Persons With Diabetes in Remission: A Randomized and Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting.
研究概览
简要总结
Patients with diabetes at high risk of ulceration require a perfect fitting shoe to avoid high shear and pressure forces. Neuropathy skews sensory perceptions and can alter the proper selection of the therapeutic footwear.
The aims of study were to evaluate the ability of high-risk patients with diabetes in remission to select the proper therapeutic footwear and to validate a novel 3D foot scanner app for selecting the proper fitting therapeutic footwear.
详细描述
A Randomized Controlled Clinical Trial in 30 patients with a previous healed diabetic foot ulcer.
After parallel randomization (1:1) patients will be enrolled into two different groups:
- Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences;
- Patients that will acquire a specific size and model according to result of a novel mobile app 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).
Validation of proper therapeutic footwear fitting will be performed by a specialized podiatrist after acquisition of shoes in both groups.
Therapeutic Footwear will be recommended to change when following ill fitting reason been found: excessive length or tight, or compromise with toes
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
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
- •High risk patients according to the International Working Group Diabetic Foot Guidelines (IWGDF-risk 3).
- •Healed diabetic foot ulcer at the moment of inclusion.
- •Capability to walk autonomously without walking aids.
- •Diabetic Peripheral neuropathy.
排除标准
- •Major amputation in the contralateral limb (below or above the knee).
研究组 & 干预措施
Standard Therapeutic Footwear prescription group
- Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences
Therapeutic Footwear prescription based on a 3D Foot scanner
- Patients that will acquire a specific size and model according to result of a novel mobile app 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).
干预措施: 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). (Other)
结局指标
主要结局
The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting.
时间窗: 1 week
Validation of proper therapeutic footwear fitting was performed by a specialized podiatrist after acquisition of shoes in both groups. TF was recommended to change when following ill fitting reason were found: excessive length or tight, or compromise with toes
次要结局
- Number of participants with an ulcer occurrence event(1 month)
研究者
Jose Luis Lazaro Martinez
Prof. Dr
Universidad Complutense de Madrid