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临床试验/NCT05974982
NCT05974982已完成1 期

Comparison of the Outcome of Treatment With Autologous Platelet Rich Plasma Versus Conventional Therapy for Patients Presenting With Chronic Venous Leg Ulcers

Jinnah Postgraduate Medical Centre1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Width of ulcer

研究概览

简要总结

The use of PRP has dramatically increased in the fields of orthopedics, spine surgery, reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other fields. In this experimental study, the treatment outcome of autologous PRP was assessed in comparison to conventional therapy among patients with chronic venous leg ulcers.

详细描述

Venous ulcers are the most common form of leg ulcers which have a significant impact on quality of life and work productivity. In addition, the costs associated with the long-term care of these chronic wounds are substantial. Conventional therapies such as dressings, surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory healing since these treatments are not able to provide necessary growth factors that can modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple, affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly good results. Since it is an autologous method, it is biocompatible and safe. Data from this would help in establishing it as a treatment of choice, thereby leading to a reduction in cost and benefiting the patient both financially and psychologically.

PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet-derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, and transforming growth factor. These growth factors are important in modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis during the healing process.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 30-80 years of any gender presented with chronic venous leg ulcers

排除标准

  • •Patients with history of peripheral arterial disease.
  • •Patients with history of acute venous thromboembolism.
  • •Patients with platelet count less than
  • •Patients with history of bleeding disorders.
  • •Patients with history of osteoporosis.
  • •Patients with history of peripheral neuropathy.
  • •Pregnant patients assessed by history and confirmed by dating scan.
  • •Patients with history of congestive cardiac failure, chronic liver disease, asthma, COPD, or stroke.

研究组 & 干预措施

Conventional therapy

Active Comparator

These patients were treated conservatively by compression using graduated elastic stockings below the knee and dressing using saline and vaseline gauze weekly for 6 weeks.

干预措施: Conventional therapy (Other)

Platelet-rich plasma

Experimental

Under aseptic precautions 20 ml of venous blood was drawn and added to a test tube containing acid citrate dextrose in a ratio of 9:1 (blood: Acid citrate dextrose), centrifuged at 5000 rpm for 15 min to separate the red blood cells from the platelets and plasma. Then the supernatant and the buffy coat composed of platelets and plasma were collected and centrifuged again at 2000 rpm for 5-10 min. The bottom layer about 1.5 ml was taken and 10% calcium chloride was added (0.3 ml for 1 ml of PRP). Then the activated PRP was applied to the wound after proper surgical debridement and was dressed with a non-absorbent dressing (paraffin gauze). This process was repeated once weekly for 6 weeks.

干预措施: PRP (Biological)

结局指标

主要结局

Width of ulcer

时间窗: 9 months

Width of ulcer in cm at the end of treatment

Complete healing

时间窗: 9 months

Complete healing is defined as 100% epithelialization

Length of ulcer

时间窗: 9 months

Length of ulcer in cm at the end of treatment

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Faiza Inam Siddiqui

Resident dermatologist (fcps)

Jinnah Postgraduate Medical Centre

研究点 (1)

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