The Relationship of Hemoglobin A1c and Diabetic Wound Healing
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Hgb A1c Level
研究概览
简要总结
The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will be done to evaluate impact on time to wound closure.
详细描述
This is a prospective randomized controlled study evaluating the relationship of hemoglobin A1c in diabetic wound healing. Length of time for wound closure will be compared using four treatment options.
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
- None
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
- •>18 years of age
- •Diabetic (Type I and Type II)
- •Ulceration of the foot at least one centimeter in width/length
- •Ulceration at least 0.2 centimeters in depth
排除标准
- •Ulceration width/length > 7.5 centimeters
- •Wound depth > 1.25 centimeters
- •Purulent, excessive drainage and/or other signs of infection (i.e. erythema, edema, warmth)
- •Inability to provide informed consent
- •Inability to swallow pills (vitamin C supplement)
- •Patients with concurrent renal problems
- •Patients with medication contraindications to Vitamin C and/or topical wound dressings
研究组 & 干预措施
Bacitracin wound care dressing alone
Bacitracin wound care dressing alone
干预措施: Bacitracin (Drug)
Bacitracin with Vit C
Bacitracin wound care dressing with Vitamin C supplementation
干预措施: Bacitracin (Drug)
Bacitracin with Vit C
Bacitracin wound care dressing with Vitamin C supplementation
干预措施: Vitamin C (Dietary Supplement)
AmeriGel® wound care dressing alone
AmeriGel® wound care dressing alone
干预措施: AmeriGel® (Drug)
AmeriGel® with Vit C
AmeriGel® wound care dressing with Vitamin C supplementation
干预措施: AmeriGel® (Drug)
AmeriGel® with Vit C
AmeriGel® wound care dressing with Vitamin C supplementation
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Hgb A1c Level
时间窗: Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
Hgb A1c measures the average blood glucose over three months (% of hemoglobin). All subjects will be asked to get their hemoglobin A1c level at the beginning of the study and every three months for as long as they participate in the study.
次要结局
- Length of Time for Wound Closure(Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months)
- Wound Area Measurements(Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months)
研究者
Susan Hassenbein
Clinical Research Associate
Milton S. Hershey Medical Center