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临床试验/NCT02134132
NCT02134132已完成1 期

Utilization of Umbilical Cord Blood-derived Platelet Gel for Treatment of Diabetic Foot Ulcers,a Randomized Double Blind Clinical Trial

Royan Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
pain

研究概览

简要总结

Diabetes is a multiorgan disease and considered a major health problem in different societies. One of the complications the pain particularly in the extremities resulting from a process known as diabetic foot ulcer. The diabetic patients are subjected to many complications because of foot ulcers, many of them like as chronic wound disease or pressure ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to nursing care and take too long until pain relief. Among many tested materials and works for wound healing such as debridement, tissue oxygenation, and skin transplantation, platelet-derived compounds are allocated the pivotal position between investigators to tissue regeneration and shortening the wound healing process.

Many of platelet components are procured from platelet rich plasma (PRP) from whole blood donation. Furthermore, it requires to an additional purification step to diminish the volume and facilitate handling in some studies. It means that platelet concentrates (PCs) may be obtained leading to more concentrated platelets in lower volume.

Two types of granules in platelet is responsible for storage of many useful and different growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the ability to growth and differentiation of numerous cells. Also, the antibacterial effect of these growth factors has been reported.

To better efficacy and comfortable utilization of platelet, it is feasible to form the platelet gel and then apply on wound sites.

This study is a double blind randomized controlled trial to evaluate the positive effects of umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.

详细描述

In this study all qualified patients (based on the inclusion and exclusion criteria) were randomly allocated into three study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma gel, group B (placebo) received platelet poor plasma gel, and group C received lubricant gel.

All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with diabetic foot ulcer are selected.On average,in each instance, the amount of platelets in the peripheral bloodis4 to6 times the baseline level.

Group A (interventional): application of 20-30mL of gel from platelet rich plasma (PRP) Group B (placebo): application of 20-30mL of gel from platelet poor plasma (PRP) Group C (control): application of 20-30 mL of lubricant gel (used typically for sonography)

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
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of at least 4 weeks hospitalization
  • Uncontrolled diabetes
  • ejection fraction > 30%

排除标准

  • mechanical origin for wound
  • history of infectious, systemic diseases, Immune deficiency and coagulation disorders

结局指标

主要结局

pain

时间窗: 3 months

Evaluation the pain reduction by VAS measurement in patients with peripheral artery Disease.

ABI

时间窗: 3 months

Evaluation the Ankle Brakial Index (ABI) in patients 3 months after PG utilization.

次要结局

  • Quality of life(3months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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