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临床试验/NCT07294521
NCT07294521招募中1 期

Efficacy of Platelet-rich-Fibrin Gel in Patients With Chronic Leg Ulcers

Pak Emirates Military Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月16日最近更新:
干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
50% improvement in Bates Jensen wound assessment tool (BWAT) score

研究概览

简要总结

Platelet rich Fibrin (PRF) gel is an emerging as a novel treatment option for chronic leg ulcers and has the potential to become the 1st line option in these conditions. The objective of our study will be to assess the efficacy of PRF gel dressing in patients with non-infective chronic leg ulcers.

详细描述

Chronic leg ulcers (CLU) affect approximately 1% of the adult population and the prevalence increases significantly with age. The causes of CLU are mainly non-infective and include neuropathy, venous and arterial disease followed by less common causes like metabolic and hematological disorders. Leg ulcers severely impact the patients' quality of lives and frequently result in impaired mobility and financial dependence. There are several validated tools for the objective assessment of the ulcer severity. Bates Jensen wound assessment tool (BWAT) is one of these measures which will be originally developed for assessing pressure wounds but has been validated for other wounds such as CLU. BWAT consists of 13 scored items and can be used as a comprehensive tool for initial assessment as well as an indicator of treatment response.

The management is mainly supportive and depends on the underlying aetiology but there is a dearth of targeted wound management options that promote healing. Platelet rich Fibrin (PRF) gel is an emerging as a novel treatment option for chronic leg ulcers and has the potential to become the 1st line option in these conditions . The objective of our study will be to assess the efficacy of PRF gel dressing in patients with non-infective chronic leg ulcers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All male and female patients more than 35 years old with Chronic Leg Ulcers, presenting to the OPD will be included.

排除标准

  • Patients with clinical signs of infected ulcers, patients in sepsis and immunosuppressed individuals will be excluded.

研究组 & 干预措施

PRF group

Experimental

Enrolled patients with chronic leg ulcers who will be administered PRF gel

干预措施: Platelet rich Fibrin (PRF) (Biological)

结局指标

主要结局

50% improvement in Bates Jensen wound assessment tool (BWAT) score

时间窗: 1 months

Bates Jensen wound assessment tool (BWAT) is one of these measures which will be originally developed for assessing pressure wounds but has been validated for other wounds such as Chronic leg Ulcer. BWAT consists of 13 scored items and can be used as a comprehensive tool for initial assessment as well as an indicator of treatment response. The score ranges from 9 to 65 with higher scores mean worse healing (tissue degeneration), lower scores indicate improvement (regeneration).

次要结局

未报告次要终点

研究者

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

Dr. Ahsan Tameez-ud-din

Registrar Dermatology

Pak Emirates Military Hospital

研究点 (1)

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