NCT01594762已完成3 期
A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Number of Participants With Clinical Response
研究概览
简要总结
The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.
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
- Triple (Participant, Care Provider, 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
- •Diabetes mellitus.
- •Male or female at least 18 years old.
- •Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
- •Subject is to be treated on an outpatient basis.
- •Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
- •Localized mild infection of the ulcer.
- •The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
- •Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.
排除标准
- •IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
- •IDSA-defined severe infection, including systemic toxicity or metabolic instability.
- •Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
- •> 1 infected foot ulcer.
- •Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
- •Subject has received a systemic antibiotic within 48 hours prior to Screening.
- •Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
- •Bone or joint involvement is suspected based on clinical examination or plain X-ray.
- •Clinically significant peripheral arterial disease requiring vascular intervention.
- •Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.
研究组 & 干预措施
Topical pexiganan cream 0.8%
Experimental
Drug: Topical pexiganan cream 0.8%
干预措施: Topical pexiganan cream 0.8% (Drug)
Topical placebo control
Placebo Comparator
Drug: Topical placebo cream
干预措施: Topical placebo cream (Drug)
Topical placebo control
Placebo Comparator
Drug: Topical placebo cream
干预措施: Standard wound care (Other)
Topical pexiganan cream 0.8%
Experimental
Drug: Topical pexiganan cream 0.8%
干预措施: Standard wound care (Other)
结局指标
主要结局
Number of Participants With Clinical Response
时间窗: 28 days
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAE)(28 days)
- Number of Participants With Microbiological Response(28 days)
研究者
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