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

NCT07294521 | Recruiting Early Phase 1

• 1 other identifier: DERM112025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Leg Ulcer

Keywords

Chronic leg ulcer; Platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PRF group

EXPERIMENTAL

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

Biological: Platelet rich Fibrin (PRF)

Interventions

Platelet rich Fibrin (PRF) BIOLOGICAL

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)

PRF group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Study Officials

• Prof. Moizza Tahir, MBBS, FCPS, FRCP

  Pak Emirates Military Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahsan Tameez Ud Din, MBBS

CONTACT

(+92 051) 9273480; ahsantameezuddinmalik@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar Dermatology

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 16, 2025
• Primary Completion: April 12, 2026
• Study Completion (Estimated): May 12, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)