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

Pak Emirates Military Hospital

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Chronic Leg Ulcer

Treatments: Biological: Platelet rich Fibrin (PRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT07294521

DERM112025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

PRF group

Experimental group

Description:

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

Treatment:

Biological: Platelet rich Fibrin (PRF)