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
- 1/2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Efficacy endpoint:
研究概览
简要总结
Galnobax® is a new gel which potentiates the wound healing process by modulation of several impaired diabetic wound healing processes. The pre-clinical experiments indicates that Galnobax® enhances collagen turnover and deposition, induces nitric oxide, inhibits the cAMP pathway, reduces oxidative stress of the cells at the wound site. This study 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 upon time taken for the ulcer to heal and close will also be studied in the phase. The study will recruit 50 subjects of which 40 subjects competitively in India and Malaysia and 10 subjects in USA. Out of subjects recruited in India, 16 willing subjects will be considered for pharmacokinetic study of Galnobax. 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. There are four groups in the trial: three treatment groups and one placebo control group.
The recruitment for the study is completed and the last patient was enrolled on 31-Jan-2015.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having single or up to two ulcers, minimum 4.0 cm apart, below knee ulcer of at least 4 weeks 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 as determined by clinical examination and complete hemogram Ulcer area (length x width) measurement between 1.5 square centimeter and 10 square centimeter, inclusive and post debridement ulcer area less than or equal to 12 square centimeter Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner’s classification system.
排除标准
- •Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis Patients with target limb cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator.
结局指标
主要结局
Efficacy endpoint:
时间窗: Efficacy endpoint: | Week 12 from baseline / wound closure which ever is earlier | Safety endpoint: | nd of follow up phase
Reduction in area and volume of ulcers
时间窗: Efficacy endpoint: | Week 12 from baseline / wound closure which ever is earlier | Safety endpoint: | nd of follow up phase
Safety endpoint:
时间窗: Efficacy endpoint: | Week 12 from baseline / wound closure which ever is earlier | Safety endpoint: | nd of follow up phase
Incidence of adverse events (AEs)
时间窗: Efficacy endpoint: | Week 12 from baseline / wound closure which ever is earlier | Safety endpoint: | nd of follow up phase
次要结局
- Efficacy endpoint:(Time taken for healing and closure of wound in different groups)