A Double-Blind Therapeutic Exploratory Clinical Study to Evaluate the Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- - Time to healing
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan compared to placebo on the healing of chronic leg ulcers in diabetes patients.
Hypothesis: Through its ability to activate tissue macrophages and counteract diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the healing of leg ulcers in diabetic patients.
详细描述
Diabetes predisposes to ulceration of the foot through a variety of processes, including neuropathy and peripheral arterial disease. Once the skin is broken, healing is frequently delayed and the ulcer develops the biology of a chronic wound. The factors underlaying delayed healing in chronic wounds are not well understood but include the effects of repeated trauma, tissue ischemia, infection, defective white cell function, altered immune processes, and altered expression of tissue cytokines and enzymes.
Management is based on regular cleansing and debridement, off-loading and treatment of intercurrent infection with antibiotics. There are no interventions in routine use, which target aspects of chronic wound biology directly.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 diabetes mellitus
- •Age>= 18 years
- •Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones
- •Study wound located on the foot or lower leg
- •Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
- •Adequate circulation to the foot, evidenced by a palpable pulse on the study foot
- •Study wound > 1.0cm2 but < 20.0cm2
- •Written informed consent
排除标准
- •Pregnancy, lactation or absence of adequate contraception for fertile women
- •Ankle/Brachial Index < 0.7
- •Severe malnutrition
- •Clinical evidence of gangrene on any part of the foot with the study wound
- •Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge on day 0
- •One or more medical condition(s) that in the opinion of the investigator would make the patient an inappropriate candidate for the study
- •Active osteomyelitis of the foot with the study wound
- •Necrotic toes on the foot with the study wound
- •Surgical procedure (other than debridement) on the foot with the study wound the last 21 days prior to screening
- •Study wound over a Charcot's joint
- •Evidence of deep tissue infection of the study wound at day 0
- •Non-study wound on the study foot that is located within 5.0cm from the study wound at day 0
- •Random blood sugar reading > 450 mg/dL
- •Alcohol or drug abuse
- •Participation in other clinical studies in the last 4 weeks
结局指标
主要结局
- Time to healing
次要结局
- Number of patients with complete healing of treated ulcers after 12 weeks of treatment
- Percentage reduction in ulcer area of treated ulcers after 12 weeks of treatment
- Percentage weekly reduction in ulcer area in treated ulcers
- Safety