Developing a Diabetic Foot Ulcer Protocol in a Multi-ethnic, Underserved Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- decrease in size of wound
研究概览
简要总结
The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.
详细描述
This pilot study will be conducted in Harris County Hospital District (HCHD) Community Health Centers and Wound Care Clinics.
The study will use random assignment of patients who meet inclusion criteria to: postoperative shoe with or without collagen; removable Air-boot with or without collagen; or monitored Air-boot with or without collagen. All treatment is standard of care.
Enrollment will occur at a clinic appointment. During the consent appointment, follow-up will be scheduled. Patients whose wound meets study criteria will be approached by a Podiatrist or therapist during a wound care visit. An A1c will be obtained, if not done within the past 3 months. A convenience sample will be drawn from people with diabetes, aged 18 or more, who meet inclusion criteria.
Frequency of visits will be:
- patients with monitored Air-boot: weekly
- all others: every 2 weeks At each visit there will be a dressing change, wound assessment and review of how many times shoe/boot was removed or not used during the preceding 1 or 2 weeks.
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
- 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
- •Adult - over 18 years of age
- •Diabetes with an A1c of less than or equal to 9% - if no A1c result is available within the past 3 months, one will be drawn to qualify the patient for the study
- •No evidence of circulatory compromise
- •Posterior tibial or pedal pulse present on palpation
- •No pallor on elevation
- •No dependent rubor
- •Loss of sensation on forefoot using monofilament
- •Wound or callus on only 1 foot
- •Wound Classification - Wagner Grade 1, non-infected
- •Ulcer present for 1 - 3 months
- •Ulcer of forefoot only
- •No previous ulcer of that foot or amputation of either extremity
- •Wound size < 1" diameter
- •Wound bed pink
排除标准
- •Diagnoses with unpredictable trajectory or healing ability, i.e.
- •Psychiatric disorders
- •ESRD not eligible for dialysis
- •Previous lower extremity amputation
- •Charcot foot
- •Evidence of circulatory compromise
- •Absence of pulses
- •Decreased capillary refill (> 3 seconds)
- •Trophic skin changes - shiny, hairless toes
- •Ankle Brachial Index < 0.8
结局指标
主要结局
decrease in size of wound
时间窗: 6 months
次要结局
- non-healing wound(6 months or less)