CTRI/2011/09/001984已完成2 期
A Phase II, Randomized, Prospective, Double blind, Parallel group, Multi-center Study to determine the Safety and Efficacy of GRANEXIN GEL in the Treatment of Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 8
- 主要终点
- The mean percent wound closure from baseline to 12 weeks
研究概览
简要总结
It is a double blind, parallel groupMulticentric study in which 92 patients with Diabetic Foot Ulcer will beenrolled. The study involves twotreatment groups:
**Group A:**GRANEXINGEL plus standard of care in treatment of diabetic foot ulcer
**Group B:**Standardof care in treatment of diabetic foot ulcer.
The patients would be treatedwith 100μM concentration of GRANEXIN GEL will be applied at Day 0, Day 3, Week 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11 and 12 along with standard of care and the controlgroup would be treated with standard care alone. The endpoint of the studywould be, mean percent of wound closure from baseline, Subject self-assessmentof intensity of pain, and complete wound closure, defined as 100%epithelialization of the wound and the absence of drainage from the wound.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged 18 years and older.
- •Female subjects must be post-menopausal or surgically sterilized.
- •Female of child-bearing potential must have negative pregnancy test at screening, and agrees to use hormonal contraceptive or intra-uterine device (IUD) or diaphragm with spermicide or condom with spermicide or abstinence throughout the study.
- •Diabetes mellitus (type I or II) with an HbA1c < 10.0%.
- •Diagnosis of neuropathic foot ulcer.
- •Cutaneous, full thickness (University of Texas grade A1), below ankle surface ulcer between 0.5 cm2 and 40 cm2 post debridement.
- •A viable, granulating wound as per investigators discretion.
- •Ulcer present for at least 4 weeks prior to screening day.
- •An Ankle Brachial Index between 0.70 and 1.3 measured at screening.
- •Signed informed consent form.
排除标准
- •Decrease or increase in the ulcer size by 30% or more during 7 day screening period.
- •Cannot tolerate the off-loading method or comply with standard of care.
- •An ulcer which shows signs of severe clinical infection, defined as pus oozing from the ulcer site.
- •The ulcer to be treated requires operative debridement.
- •An ulcer positive for _-hemolytic streptococcus upon culture.
- •Requirement for total contact casts.
- •The ulcer has more than 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure.
- •Highly exuding wounds (wounds that require a daily dressing change).
- •ABPI 0.7 or 1.3 or ankle systolic pressure 70 mm Hg.
- •Subjects with systemic infections.1
- •On Doppler waveform analysis on the dorsalis pedis and posterior tibial arteries monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or b.
- •A toe: brachial index 0.7 or 1.3, or c.
- •Transcutaneous oxygen pressure (TcpO2) 40 mm Hg
- •Presence of an active systemic or local cancer or tumor of any kind (with the exception of nonmelanoma skin cancer).
- •Subjects with Congestive heart failure New York Heart Association class II to IV or Coronary heart disease with ST segment elevation myocardial infarction (STEMI) or Coronary Artery Bypass Graft (CABG) or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the last 6 months.
- •Subjects with active connective tissue disease.
- •Subjects with Acute Charcots neuro-arthropathy as determined by clinical and/or radiographic examination.
- •Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation.
- •Pregnant or nursing subjects.
- •Subjects with Uncontrolled anemia (Hb 10 g/dL in females and 12 g/dL in males).
- •Subjects with eGFR 25 mL/min.
- •Known prior inability or unavailability to complete required study visits during study participation.
- •A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subjects medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.
- •Use of a platelet-derived growth factor within the 28 days prior to screening.
- •Use of any investigational drug or therapy within the 28 days prior to screening.
结局指标
主要结局
The mean percent wound closure from baseline to 12 weeks
时间窗: The mean percent wound closure from baseline to 12 weeks
次要结局
- Subject self-assessment of intensity of pain.(during enitre study)
- Mean percent wound closure at 4 weeks(at 4 weeks)
- Time taken for 50% wound closure.(during enitre study)
- Time to complete wound closure where complete wound closure will be defined as 100% epithelialization of the wound and the absence of drainage from the wound(during enitre study)
研究者
研究点 (8)
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