The Impact of Custom 3D Printed Footwear on Diabetic Foot Ulcer Healing: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improved Ulcer Healing Rates
研究概览
简要总结
•The project aims to explore the effectiveness of custom-made 3D printed footwear in promoting the healing of diabetic foot ulcers. This study will compare the healing rates, comfort, usability, and long-term outcomes of patients using 3D printed footwear against those using standard footwear or other treatments. By focusing on how personalized footwear can redistribute pressure on the foot, the trial seeks to determine if this innovative approach can accelerate ulcer healing, enhance patient comfort, and reduce recurrence rates. Additionally, the project will assess the cost-effectiveness and overall patient satisfaction with 3D printed footwear, potentially leading to new advancements in diabetic foot care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults 18+ with a diagnosis of diabetes mellitus.
- •Presence of plantar trophic foot ulcers.
- •Ulcer grade 1 or 2 on the Wagner Ulcer classification system.
- •No signs of active infection at the ulcer site.
- •Ability to comply with study procedures and follow-up visits.
排除标准
- •Major foot deformities (eg: Charcot foot)
- •Severe peripheral arterial disease.
- •Cognitive impairment preventing informed consent.
结局指标
主要结局
Improved Ulcer Healing Rates
时间窗: At Baseline
Better Pressure Redistribution
时间窗: At Baseline
Enhanced Patient Comfort and Satisfaction
时间窗: At Baseline
Reduced Ulcer Recurrence
时间窗: At Baseline
Cost-Effectivenes
时间窗: At Baseline
次要结局
- Enhanced Patient Comfort & Satisfaction(Reduced Ulcer Recurrence)
研究者
Ozair Hassan
SAVEETHA MEDICAL COLLEGE