Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Time to New Foot Complication Among All Randomized Participants
研究概览
简要总结
Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot ulcer, which became infected. This is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the occurrence of diabetic foot ulcers in Veterans at high risk of a diabetic foot ulcer.
详细描述
Population: Up to 200 Veterans at high risk of a diabetic foot ulcer
Site: VA Maryland Health Care System (VAMHCS)
Study Duration: Approximately 5 years
Study Design: Randomized double-blind clinical trial comparing a) a daily foot care regimen with cloths containing 2% chlorhexidine to b) a daily foot care regimen with cloths not containing 2% chlorhexidine
Objectives:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults >=18 years
- •Clinical diagnosis of diabetes
- •At high risk for a new diabetic foot ulcer due to: 1)Past history of diabetic foot ulcer or 2)Past history of major foot surgery including partial foot amputation or 3)Past history of major foot infection or 4)Neuropathy and onychomycosis and hemoglobin A1C >8% or 5)Neuropathy and peripheral vascular disease or 6)Dialysis or 7)Past history of Charcot foot or 8)Past history of peripheral vascular surgery or angiography with stent
- •Two feet (can have amputation of part of the foot)
- •At least one foot without a foot ulcer
- •Permanent mailing address suitable for provision of specimen collection materials and telephone suitable for monthly follow-up
- •Able to give written informed consent
排除标准
- •Amputation of the foot planned to treat current foot ulcer or wound
- •Current foot infection
- •Use of topical chlorhexidine on feet 7 days prior to randomization
- •History of an allergic reaction to chlorhexidine
- •Unable to use wipes for foot care
- •Inability to walk
- •Life expectancy less than 12 months
- •Plans to move out of the area in the next 13 months
- •Requires equivalent of institutional care (e.g. nursing home)
- •Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study
研究组 & 干预措施
Chlorhexidine
Participants randomized to the intervention will wash their feet using 2% CHLORHEXIDINE GLUCONATE CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
干预措施: Chlorhexidine (Drug)
Placebo
Participants randomized to the placebo will wash their feet using COMFORT BATH CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to New Foot Complication Among All Randomized Participants
时间窗: 12 months
Time in days to new foot complication (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to new foot complication; the results we are reporting are number of participants who developed a new foot complication in the 12 months post randomization). A new foot complication is defined as either 1) a new chronic (present 28 days from initial diagnosis) foot ulcer or wound or 2) a moderate or severe foot infection (as defined by IDSA Diabetic Foot Infection Severity classification: Table 2) not from an existing ulcer or 3) a foot amputation for a new ulcer.
次要结局
- Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet(4 weeks after stopping the intervention (approximately 13 months after randomization))