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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Leg Ulcer
• Intervention / Treatment: Biological: Platelet rich Fibrin (PRF)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ahsan Tameez Ud Din, MBBS; Phone Number: (+92 051) 9273480; Email: ahsantameezuddinmalik@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan
      • Recruiting
      • Pak Emirates Military Hospital
      • Contact: Ahsan Tameez Ud Din, MBBS; Phone Number: (+92 051) 9273480; Email: ahsantameezuddinmalik@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF group; Enrolled patients with chronic leg ulcers who will be administered PRF gel	Biological: Platelet rich Fibrin (PRF); PRF is derived solely from the patient's own blood and does not contain any non-autologous additives, such as anticoagulants or bovine thrombin, as first-generation platelet concentrates (like some forms of PRP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
50% improvement in Bates Jensen wound assessment tool (BWAT) score	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).	1 months

Collaborators and Investigators

• Sponsor: Pak Emirates Military Hospital
• Investigators: Principal Investigator: Prof. Moizza Tahir, MBBS, FCPS, FRCP, Pak Emirates Military Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): April 12, 2026
• Study Completion (Estimated): May 12, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Platelet rich fibrin; Chronic leg ulcer
• Other Study ID Numbers: DERM112025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers as a general rule but during the publication process, it may be shared on editorial demand/ reviewer's comments in order to prove the authenticity of the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No