跳至主要内容
临床试验/NCT06281483
NCT06281483招募中不适用

Efficacy of Platelet-rich Plasma Versus Platelet-rich Fibrin Versus Conventional Treatment in Chronic Non-healing Skin Ulcers: a Comparative Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Any adverse effects related to treatment modality

研究概览

简要总结

To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment.

详细描述

An ulcer is a breach in the continuity of skin, epithelium or mucous membrane caused by sloughing out of inflamed necrotic tissue. Chronic ulcers are formed because of the failure in the orderly process that produces anatomic and functional integrity. Ulcers are considered chronic if they show no tendency to heal after six weeks of appropriate treatment or those that have not fully healed after 12 months.

Despite greater understanding of the biology of wound healing over the past 20 years, some chronic wounds, such as venous leg ulcers, pressure ulcers, and diabetic foot ulcers, are recalcitrant to healing.

In addition to local wound-related factors (eg, ischemia, infection) and patient related factors (eg, diabetes, old age, obesity, malnutrition) that can impair healing, reduction in tissue growth factors, an imbalance between proteolytic enzymes and their inhibitors, and the presence of senescent cells seem to be particularly important in chronic wounds.

Regardless of the underlying etiology, non-healing ulcers tend to have chronic pain, discharge, sleep impairment, and subsequent adverse repercussions in quality of life and productivity, and impose a huge economic burden on the medical system.

In the United States, chronic ulcers including decubitus, vascular, inflammatory, and rheumatologic subtypes affect 6 million people, with increasing numbers anticipated in a growing elderly and diabetic populations.

研究设计

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

入排标准

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

入选标准

  • Patients presenting with cutaneous ulcers greater than six weeks of duration and a size ranging between 0.5 and 10 cm, having a normal platelet count and hemoglobin >10 gm%.

排除标准

  • Patients with known bleeding disorders, and/or on oral anticoagulant therapy, uncontrolled diabetes, proven malignancy.
  • Patients who are pregnant or lactating.
  • Patients with actively infected ulcers, clinically defined by purulent discharge, green discoloration or fever, or positive culture, ulcers with exposed bone with no underlying granulation tissue, HIV, HCV, HBV patients.
  • Patients who are with unrealistic expectations and unwilling to give consent for treatment or photography.

研究组 & 干预措施

PRF / Group B

Active Comparator

12 patient

干预措施: platelet-rich fibrin (Other)

Group C (the control group)

Active Comparator

12 patient

干预措施: Surgical debridement, normal saline washing and dressing coverage (Other)

结局指标

主要结局

Any adverse effects related to treatment modality

时间窗: Four months of follow up after eight sessions of treatment (six months total)

Any adverse effects related to therapy will be recorded immediately at each sitting and statistically analyzed for comparison between groups of trial.

Objective assessment of ulcer size for effectiveness, using Image J software.

时间窗: Four months of follow up after eight sessions of treatment (six months total)

Photographs will be obtained at baseline, one month after and at end of eight sessions (two months) with a Nikon D3300 AF-P 18-55 VR 24.2 Megapixels® digital camera and will be standardized for light and distance from the ulcer.

Pain assessment

时间窗: Four months of follow up after eight sessions of treatment (six months total)

Pain assessment will be done using Visual analogue scale (scale: 0-10).The Visual analogue scale provides a continuous scale for subjective magnitude estimation and consists of a straight line, the limits of which carry a verbal description of each extreme of the pain to be evaluated. The line is usually 10 cm long and vertical. The Visual analogue scale is often used to evaluate the analgesic properties of various treatments and accomplishes this by measuring either pain relief or pain severity.

次要结局

未报告次要终点

研究者

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

Mohamed Aboshabana Hussein Mohamed

Assistant Lecturer of Dermatology and Venereology

Kafrelsheikh University

研究点 (1)

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