Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers and Improving Insulin Sensitivity: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of healing of diabetic ulcers measured by ulcer size
研究概览
简要总结
This study is designed to evaluate if Vasculera, a marketed medical food product, will improve the rate and extent of healing of diabetic ulcers.
详细描述
This study is designed primarily to compare the rate and extent of healing of diabetic ulcers in people treated with or without Vasculera while maintaining a standard of care (SOC) therapeutic regimen. The study will also examine the effects of Vasculera on anti-diabetic medication requirements and markers of microvascular disease. Subjects will be stratified by whether or not they receive hyperbaric oxygen therapy (HBOT) as part of their SOC treatment regimen. In addition, the study will examine the ability of Vasculera to improve glycemic control and reduce anti-diabetic medication requirements (oral or injectable insulin) and will gather preliminary information on the ability of Vasculera to improve microvascular blood flow and oxygen delivery peripheral tissues including ulcerative lesions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either gender, between 25-85 years old
- •Diagnosis of type II diabetes
- •Presence of a grade I-III skin ulcer of diabetic origin and at least 1 cm in diameter for more than 60 days and not improving despite standard conventional care without HBOT
- •Treatment with oral anti-diabetic agents and/or insulin for at least 1 year. Dose must be stable for at least 3 months.
- •Not using any other product for control of serum glucose including medical foods, neutraceuticals or dietary supplements
- •Consistent dietary habits
- •Able to understand and sign informed consent document
排除标准
- •age less than 25 years or greater than 85 years
- •Skin ulceration of other than diabetic etiology
- •diagnosis of type I diabetes
- •use of any other serum glucose modifying agent, other than stable prescribed anti-diabetic medication regimen within 12 weeks of screening visit
- •use of nutritional supplements specifically for anti-oxidative purposes (e.g., multivitamins allowed)
- •history of collagen vascular disease
- •taking corticosteroids in any dose, by any route
- •no history of therapy with pentoxyphylline or cilostazol for 2 months prior to the screening visit and for the duration of the study
- •history of any intestinal disease that might interfere with absorption of study products
- •any active malignancy or history of malignancy within 3 years of the screening visit,, except basal cell carcinoma or cervical carcinoma in situ curatively treated
- •screening AST, ALT, alkaline phosphatase, bilirubin >1.3 times the upper limit of normal for the reference laboratory
- •serum creatinine >3.0
- •diabetes mellitus not on stable therapy for at least 3 months
- •history of chronic pancreatitis
- •uncontrolled hypertension (DBP >100, SPB >160)
- •unstable angina, other uncontrolled cardiac disease including NYHA CHF Class III or IV
- •pregnant or lactating women
- •known history of allergies to citrus, diosmin, or Alka-4 Complex
- •history of substance abuse, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
- •Consumption of more than one (1) unit of alcohol daily. For the purposes of this study a unit of alcohol is defined as 12 oz. of beer, 6 oz. of wine or 1.5 oz. of hard spirits
- •Concomitant use of chlorzoxazone, diclofenac or metronidazole
- •any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study
- •participation in another clinical trial within 30 days or 7 half-lives of the prior study product, whichever is longer, of the screening visit
结局指标
主要结局
Rate of healing of diabetic ulcers measured by ulcer size
时间窗: 4 months
days to complete healinh
次要结局
- lower extremity skin oxygenation measured by trancutaneous oximetry(4 months)
- Efficacy of diabetic control measure by reduction of oral anti-diabetic medication and/or insulin requirements(4 months)
- Reduction on peripheral edema measured by leg circumferance(4 months)