An Interventional, Placebo-Controlled, Randomized, Double-blinded Dose Comparison, Phase I/II Study to Determine the Safety and Efficacy of a New Gel Formulation of Esmolol Hydrochloride (Galnobax®) for the Treatment of Diabetic Foot Ulcer (DFU)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Safety Outcome
研究概览
简要总结
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.
详细描述
This is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I/II study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application will also be studied . The total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 to 95 years, inclusive, with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
- •Subjects having below knee ulcer of at least 4 week and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons
- •Ulcer should be clinically non-infected
- •Ulcer area (length x width) measurement between 1.5 cm2 and 10 cm2, inclusive and post debridement ulcer area less than or equal to 12 cm
- •Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner's classification system
- •Recently debrided ulcer (2 weeks prior to screening) and post debridement ulcer free of necrotic debris, foreign bodies, sinus tracts, tunneling, and undermining, comprised of healthy vascularized tissue as determined by the Investigator
- •Inability to perceive 10 grams pressure using Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
- •Ankle Brachial index between 0.7 and 1.2
排除标准
- •Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis.
- •Subjects having cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator
- •Glycosylated hemoglobin (HbA1C) >12%
- •Diagnosed and/ currently unstable hypotension, heart block, cardiac failure, and other cardiac complications
- •Subject diagnosed with cancer undergoing chemotherapy
- •Revascularization surgery 4 weeks prior to signing the ICF
- •Renal failure as defined by serum creatinine >3.0 mg/dL or renal insufficiency requiring frequent dialysis
- •Poor nutritional status as measured by serum albumin <3.0 g/dL
- •Active Charcot or other structural deformity that would prevent adequate off-loading of the study foot
研究组 & 干预措施
Placebo
Placebo gel
干预措施: Placebo gel (Drug)
Galnobax 20% QD
Esmolol Hydrochloride (Galnobax) 20% gel once daily
干预措施: Esmolol hydrochloride (Drug)
Galnobax 20% BID
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
干预措施: Esmolol hydrochloride (Drug)
Galnobax 14% BID
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
干预措施: Esmolol hydrochloride (Drug)
结局指标
主要结局
Safety Outcome
时间窗: Till end of follow up period (Week 25)
Number of participant with adverse events (AEs) till end of follow-up phase in different groups
次要结局
- Efficacy Outcome(From baseline till end of treatment (Week 12 or 84 +/- 2 days))