An interventional study:Efficacy and safety of homologous platelet concentrate for the treatment of diabetic foot ulcers

Self sponsored1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2016年12月23日最近更新: 2018年12月4日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Self sponsored
入组人数: 40
试验地点: 1
主要终点: 1. Time to healthy granulation tissue formation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Diabetic ulcer is a major public heath concern. About 15% of the diabetes patients develop chronic ulcer and 25% among them undergo foot amputation due to complications of various reasons. Deficiency of various growth factors related to neo-vascularisation is one among them. Platelets concentrate are rich in many of these growth factors along with anti microbial properties. So we planned the current study to assess the efficacy in healing of the diabetic ulcer among people treated with homologous platelet concentrate in comparison with people treated with standard dressing. We also want to look into the safety of single donor homologous platelet concentrate for the treatment of diabetic ulcer and the rate of graft uptake following split skin grafting.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 95.00 Year(s)（—）
性别: All

入选标准

•1.persons with type1 or type2 diabetes with denovo lower extremity diabetic ulcers 2.male and female,between ages 18-95 3.ulcer of atleast 4weeks duration with post debridement free of sinus tracts and tunneling and atleast 4cms from any additional wound 4.HbA1C <12 5.Wound measurement between 0.
•20 sqcm 6.full thickness without exposure of bone, muscle, ligament, tendon 7.the limb had to have adequate perfusion via ABI between 0.8 -1.5 8.no H/O infectious disorders in last 6 months 9.informed consent form signed.

排除标准

•Non pregnant and non lactating women
•Not on suppressants and ART
•Ulcers of venous and arterial insufficiency
•Bleeding and Clotting disorders
•Patients on chemo and radiotherapy.