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临床试验/NCT05404295
NCT05404295已完成4 期

The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers:a Randomized Controlled Trial

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年6月10日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size.

研究概览

简要总结

Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the treatment of diabetic foot ulcers, as it provides the necessary growth factors which enhance tissue healing. Human umbilical cord blood platelet lysate (UCB-PL) contains a supraphysiological concentration of growth factors. The aim of the study is to evaluate the efficacy of umbilical cord blood platelet lysate (UCB-PL) gel for the treatment of diabetic foot ulcer.

详细描述

110 patients with diabetic foot ulcer will be randomized to receive UCB-PL gel or regular dressing with normal saline. The diabetic foot ulcers will be first debrided to remove any necrotic and infected tissues or hyperkeratotic skin. Afterward, the wound area will be cleaned thoroughly with normal saline. Ulcer length, width and surface will be measured before any study procedure. The UCB-PL gel in the treatment group and the dressing with normal saline in the control group will be applied in the ulcer, and then a few layers of sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area. This will be repeated every three days for one month. After the fist one month of treatment, the patients will be followed up for a period of 20 weeks post-treatment. Care and management efforts will be provided at each visit included cleansing and assessing of the wound, obtaining an interim wound history, including information regarding adverse events, concomitant medications and other aspects of care since the last visit. Ulcers will be photographed at two weeks, at four weeks, at two months, at four months and at six months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age>18 years old
  • •patients with diabetic foot ulcer, foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces)
  • •ulcer with area(length x width) measurement<30 cm2
  • •non-infected ulcers

排除标准

  • •venous ulcers
  • •clinical signs and symptoms of infection
  • •exposure of bone, muscle, ligaments, or tendons and the presence of tunneling

研究组 & 干预措施

Umbilical cord blood platelel lysate group

Active Comparator

A Umbilical cord blood platelel lysate gel will be applied in diabetic foot ulcer every three days for one month.

干预措施: Umbilical cord blood platelel lysate gel (Other)

Control group

Placebo Comparator

The control group will receive the clinical standard of care; removable of any necrotic, hyperkeratotic and infected tissue, cleansing of the wound with normal saline and covering of the ulcer with dressing with normal saline and then with a few layers of sterile gauze, and non-compressible bandage.

干预措施: Umbilical cord blood platelel lysate gel (Other)

结局指标

主要结局

The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size.

时间窗: six months

Primary endpoint was to investigate the efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size over the six months follow-up by using the imito-measure application.

次要结局

未报告次要终点

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

VAIA LAMBADIARI

Professor of Internal Medicine-Endocrinology

Attikon Hospital

研究点 (2)

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