Instant Total Contact Cast to Heal Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 8
- 主要终点
- Number of Participants Who Achieve Full Wound Healing.
研究概览
简要总结
Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week randomized clinical trial of 225 patients in community care in three university medical center diabetes clinics.
Aim 2. To compare the frequency of complications such as soft tissue and bone infections, iatrogenic wounds, falls and fall related injuries, and amputations among patients treated with TCC, ITCC and RCW to heal diabetic foot ulcers.
Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment groups. Using computerized activity monitors which time-stamp each step, we will evaluate both degree and magnitude of activity between groups.
Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications during the course of therapy.
详细描述
This is an investigator blinded randomized, controlled clinical trial with three parallel treatment groups of 75 adult outpatients with diabetes mellitus and a foot ulcer. The study will be conducted at five university affiliated medical centers in Arizona and Texas. The study participants and nurse coordinator will not be blinded to the treatment after randomization. Investigators will be blinded to treatment group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Men or women 18 years old or older
- •One or more foot ulcers without clinical evidence of osteomyelitis
- •Diagnosis of Diabetes Mellitus
- •University of Texas Grade 1A-B, 2A-B or 3A-B
- •ABI >0.5
- •Spanish-speaking subjects will be eligible to participate
排除标准
- •Active Charcot Arthropathy
- •ABI <0.5
- •Gangrene, active infection
- •Unable to keep research appointments
- •Wide spread malignancy or systemically immunocompromising disease
- •Alcohol or substance abuse within 6 months
- •Unreliable, unwilling or unable to comprehend informed consent
结局指标
主要结局
Number of Participants Who Achieve Full Wound Healing.
时间窗: 20 weeks
We will evaluate wounds at each clinical visit. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.
次要结局
未报告次要终点
研究者
Larry Lavery
Professor
University of Texas Southwestern Medical Center