Orthotic Treatment of Diabetic Foot Ulcers: Patient Adherence to Prescribed Wear and Effectiveness of Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Orthosis wear-time
研究概览
简要总结
The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study.
排除标准
- •Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded
- •All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)
- •scores between 12 and 8 will indicate need for extra efforts to support comprehension of instructions, and patients with scores of 7 or less will be excluded
研究组 & 干预措施
Treatment group
Patients will be given additional counseling
干预措施: Removable cam walker boot (Device)
Treatment group
Patients will be given additional counseling
干预措施: Counseling (Other)
Control group
Patients will be given standard of care.
干预措施: Removable cam walker boot (Device)
结局指标
主要结局
Orthosis wear-time
时间窗: At each clinic visit through study completion, an average of 8 months
The total time that the orthosis has been worn between clinic visits.
Foot ulcer size
时间窗: At each clinic visit through study completion, an average of 8 months
Size of the diabetic foot ulcer.
Foot ulcer healing status
时间窗: At each clinic visit through study completion, an average of 8 months
Status of the diabetic foot ulcer.
Number of foot ulcers
时间窗: At each clinic visit through study completion, an average of 8 months
The number of diabetic foot ulcers.
次要结局
未报告次要终点