CTRI/2018/11/016295招募中3 期
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (GALNOBAX®) in Treating Diabetic Foot Ulcers.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 35
- 主要终点
- Proportion of Subjects achieving Target Ulcer Closure within 12-week Treatment Phase, as assessed by blinded Investigator.
研究概览
简要总结
This study is a prospective, multicenter, randomized, double-Blind, phase 3 study to evaluate the safety and efficacy of a Gel Formulation of Galnobax® in treating Diabetic Foot Ulcers for 12 weeks in 350 patients and will be conducted in 21 centers in India from seven cities. The primary outcome will be proportion of subjects achieving target ulcer closure in 12-week treatment period and Secondary outcome will be time to target ulcer closure during the 12 weeks treatment and proportion of subjects achieving target ulcer closure till end of study assessed by blinded investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •1.Subjects, male or female, aged 18 to 65 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control 2.Subject has glycosylated hemoglobin, HbA1C, ≤ 12% 3.Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test 4.Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3 5.Presence of at least one DFU that meets all of the following criteria: a.A full-thickness ulcer of Grade A1 as per Texas classification system; b.Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement); c.No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts; 6.Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Investigator 7.Subject, if female of child-bearing potential, has a negative urine pregnancy test at Screening and willing to use acceptable methods of contraception (birth control pills, barriers) or abstinence throughout the Study 8.Subject is able and willing to comply with Study procedures including the use of an off-loading device (as applicable for the location of the ulcer) and adhere to protocol during the Study in the opinion of Investigator 9.A Subject or LAR agrees to sign informed consent form and allow audio visual recording of consent, if applicable.
排除标准
- •Subjects will not be eligible for enrolment in the Study if they meet any of the exclusion criteria listed below: 1.Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis 2.Subjects with more than three ulcers below knee 3.Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method 4.Subject has ulcers caused by a disease other than diabetes, in the opinion of the Investigator 5.Ulcer, about which the Investigator is suspicious for cancer 6.Subjects with a gangrenous or ischemic ulcer 7.Subject with ulcer that in the opinion of the Investigator, may need amputation
- •Subject with Target ulcer where wound measurement is not possible, such as ulcers between toes 9.Body mass index (BMI) > 40 kg/m2 10.Laboratory values at Screening of: Hemoglobin < 10.0 g/dL, White Blood Cells (WBC) < 2.0 X 109 cells/L, Albumin < 2.5 g/dL, eGFR < 25 mL/min 11.Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing 12.Subject has received or is currently receiving or scheduled to receive medication or therapies during the course of the Study such as Immunosuppressants, Revascularization surgery, Growth factors, Hyperbaric oxygen therapy (HBOT), Negative pressure wound therapy (NPWT), Bioengineered tissue or skin substitutes, Topical steroids, Investigational drug(s) or therapies 13.Subject with intolerance to β-blockers at any time in the past 14.Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study.
结局指标
主要结局
Proportion of Subjects achieving Target Ulcer Closure within 12-week Treatment Phase, as assessed by blinded Investigator.
时间窗: 12 weeks
次要结局
- Time to Target Ulcer Closure during the 12-week Treatment Phase, as assessed by the blinded Investigator(12 weeks)
- Proportion of Subjects achieving Target Ulcer Closure till End of Study, as assessed by the blinded Investigator(24 weeks)
研究者
研究点 (35)
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