NCT00516958已完成2 期
An Open Label, Three Arm, Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care vs. Oral Levofloxacin vs. Combined Therapy for Mild Diabetic Foot Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers
研究概览
简要总结
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic 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
- 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
- •A patient must meet all of the following inclusion criteria to be enrolled in the study:
- •Males and females > 18 years of age with diabetes mellitus (type 1 or type 2, controlled).
- •Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by IDSA guidelines and the UTC / 1B.
- •Foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy.
- •Foot ulcers located in the plantar, dorsal or malleolar areas.
- •Ulcers 1- 9 cm2 in size.
- •An accessible infection site for culture.
- •ABI by Doppler ≥ 0.8 or TcPO2 ≥ 30 mmHg.
- •Palpable pulse on the study foot (either dorsalis or posterior tibial artery).
- •Willing and able to give informed consent.
- •Willing to comply with the requirements for participation in the study.
排除标准
- •Patients are excluded if they meet any of the following criteria at the time of randomization:
- •Previous antibiotic treatment received for more than 24 hours within 72 hours of study.
- •Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns.
- •Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis).
- •The patient´s ulcer is located on the stump of an amputated extremity.
- •The patient's ulcer is due to a non-diabetic etiology.
- •Infections complicated by the presence of prosthetic materials.
- •Osteomyelitis
- •Females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding.
- •Known to have liver disease, with total bilirubin > 5 times the Upper Limit of Normal (ULN); known to have neutropenia (absolute neutrophil count <500 cells/mm3).
- •Hypersensitivity to chlorine or quinolones.
- •Need for any additional concomitant systemic antibacterial agent other than the study drug(s).
- •Concomitant glucocorticoid doses (> 5mg prednisone a day or equivalent).
- •Adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders.
- •A history of diseases of immune function (HIV, chronic granulomatous disease).
- •Any medical condition that, in the investigator´s opinion, will require dose modification of Levofloxacin to less than 750 mg a day.
- •Has received an investigational agent ≤1 month prior to the baseline evaluation.
研究组 & 干预措施
2
Active Comparator
Topical Dermacyn and levofloxacin
干预措施: Topical Dermacyn and Levofloxacin (Drug)
3
Active Comparator
Topical saline and levofloxacin
干预措施: Topical Saline and Levofloxacin (Drug)
1
Experimental
Topical Dermacyn
干预措施: Topical Dermacyn (Drug)
结局指标
主要结局
To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers
时间窗: Visit 3 (Day 10); Visit 4 (Day 24)
次要结局
- To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes(Visit 2 (Day 3); Visit 3 (Day 10))
研究者
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