CTRI/2011/09/001985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 Venous Leg Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 10
- 主要终点
- The mean percent wound closure.
研究概览
简要总结
This Phase II, prospective, study is designed as a multicenter, doubleblind, parallel group study in which subjects with venous leg ulcers will berandomly allocated to receive 100μM concentrationGRANEXIN GEL plus Standard of Care (SoC) as compared to Standard of Care alone.The total study duration for efficacy assessments is 12 weeks with additional12 weeks follow up for safety evaluations. The patients would betreated with 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.
- •Subjects with ulcers of venous origin, as clinically determined by the investigator by a positive venous reflux test (venous refilling <20 seconds) using Doppler ultrasound for at least 4 weeks prior to screening day, which have not adequately responded to conventional ulcer therapy.
- •Ulcers that extend through the epidermis but not through muscle, tendon, or bone (Stage II or III ulcers as defined by the IAET).
- •Surface ulcer between 0.5 cm2 and 40 cm2 post debridement.
- •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 or comply with compression therapy.
- •An ulcer which shows signs of severe clinical infection, defined as pus oozing from ulcer site.
- •The ulcer to be treated requires operative debridement.
- •An ulcer positive for _-hemolytic streptococcus upon culture.
- •The ulcer has more than 50% slough, significant necrotic tissue, osteomyelitis, bone, tendon, or capsule exposure or avascular ulcer beds.
- •Highly exuding wounds (wounds that require a daily dressing change).
- •Subjects with active systemic infections.
- •Subjects with clinically significant medical conditions as determined by the Investigator which would impair wound healing including renal, hepatic, hematologic, neurologic or immune disease.
- •Examples include but are not limited to: a.
- •Renal insufficiency as an estimated GFR which is 30 mL/min/1.7m2.b. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range.c. Hepatic insufficiency defined as total bilirubin 2 mg/dL or serum albumin 25 g/L.d. HbA1c 9.0%.e.
- •Hemoglobin 10 g/dL.f. Hematocrit 0.
- •Platelet count 100,
- •Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer).
- •Subjects with active osteomyelitis of the study foot.
- •Subjects with severe rheumatoid arthritis (with more than 20 persistently inflamed joints, or below lower normal limit blood albumin level, or evidence of bone and cartilage damage on x-ray, or inflammation in tissues other than joints) and other collagen vascular diseases.
- •Subjects with active connective tissue disease.
- •Treatment with systemic corticosteroids (15 mg/day), or current immunosuppressive agents.
- •Previous or current radiation therapy or likelihood to receive this therapy during study participation.
- •Pregnant or nursing subjects.
- •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 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.
时间窗: week 12 from baseline.
次要结局
- Mean percent wound closure(4 weeks from baseline)
- Time taken for 50% wound closure.(from day 3 till study exit)
- Subject self-assessment of intensity of pain.(from day 3 till study exit)
- 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.(from day 3 till study exit)
研究者
研究点 (10)
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