A Randomized Controlled Trial on Platelet Rich Plasma Gel Compared to Normal Saline Dressing of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percent reduction in the ulcer size
研究概览
简要总结
New treatments for persistent DFU have emerged, among which are the bioengineered skin substitutes, extracellular matrix proteins products, matrix metalloproteinases modulators, and growth factor therapy. Platelet rich plasma (PRP) gel has been used for stimulating wound healing since the last decade of the 20th century. This randomized trial was conducted to assess the role of PRP in gel form as a treatment for clean non-healing diabetic foot ulcer in comparison to regular dressing with saline as a control.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients of both sexes aging below 70 years with non-infected chronic foot ulcer confined to one anatomical site. Chronicity was defined as non-healing ulcer for twelve or more weeks
排除标准
- •Patients with chronic limb ischemia.
- •Evidence of osteomyelitis in the affected foot
- •Exposed tendons, ligaments or bones at the base of ulcer
- •Patients who received radiotherapy or chemotherapy at time of study or within 3 months of its beginning.
- •Patients having low peripheral platelet count, low serum albumin level or low hemoglobin level
研究组 & 干预措施
PRP gel
PRP gel was applied to the ulcer twice per week after preparation and then the ulcer was covered with Vaseline gauze, few layers of sterile gauze and crepe bandage.
干预措施: PRP gel (Drug)
Saline dressing
daily dressing of the ulcer with normal saline was done
干预措施: Saline dressing (Drug)
结局指标
主要结局
Percent reduction in the ulcer size
时间窗: 20 weeks
the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of surgery
Mansoura University