Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Chronic Non Healing Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of ulcer size
研究概览
简要总结
using platelet-rich plasma (PRP) in healing diabetic foot ulcers (DFUs), and to compare the rate of healing and final outcome with conventional therapy.
详细描述
Diabetic foot ulcers (DFU) are one of the most frequent and difficult complications in diabetes. The risk for a diabetic patient to develop an ulcer during his life is estimated as being 25%. Ulcers are a frequent cause of lower limbs amputation and 84% of lower limb amputations are preceded by ulcers .
Diabetic ulcer (DU) is not only a serious clinical problem with negative impacts on both the life quality and survival time, but also an economic burden with significant contribution to high cost and lengthy hospitalizations. Furthermore, the non healing diabetic cutaneous ulcers along with the subsequent amputations may bring about costly to treat and painful disabilities. However, healing of the DU may be improved and most of the amputations may be prevented by more effective treatments based on diabetic education .
In spite of the high prevalence and morbidity associated with DFUs, current treatment options are limited. Current standard management consists of surgical debridement followed by frequent dressing changes with tight infection and glycemic control. Despite this comprehensive approach, complication and amputation rates remain high.
The use of platelet-rich plasma (PRP) has emerged as an adjunctive method for treating DFUs.
Platelet-rich plasma (PRP) preparations were first described in the 1980s as plasma with a platelet count above that found normally in peripheral blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic patients 18 to 80 years of age, with at least one cutaneous ulcer, which did not improve significantly after at least 4 week ulcer standard treatments
- •ankle brachial index value ≥ 0.6
- •platelet count ≥ 100,000 /mm 3
- •no history of various drug or dressing allergies
排除标准
- •- ulcer is due to non diabetic etiology
- •patients blood vessels are non compressible for ankle brachial index (ABI )testing
- •the presence of an infected wound and/or osteomyelitis, and/or a completely necrotic ulcer
- •active oncological disease. systemic treatment medications like corticosteroids, immunosuppressive agents, as well as radiation or chemotherapy at the target sites within 3 weeks before this study.
- •Screening platelets count less than 100,000mm3
- •Screening hemoglobin less than10.5mg/dl
- •End stages renal disease,haematological,collagen vascular disease and bleeding disorders
结局指标
主要结局
Change of ulcer size
时间窗: 16 weeks
ulcer size will be measured with ruler/probe for length, width and depth and estimated by calculating the ulcer size in centimeter (cm 2).
次要结局
- time of wound healing(16 weeks)
研究者
Hanaa Mohammed Riad
assistant lecture
Assiut University