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

NCT ID: NCT07294521

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2026-05-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Leg Ulcer

Keywords

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Chronic leg ulcer Platelet rich fibrin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRF group

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

Group Type EXPERIMENTAL

Platelet rich Fibrin (PRF)

Intervention Type 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)

Interventions

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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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pak Emirates Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ahsan Tameez-ud-din

Registrar Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof. Moizza Tahir, MBBS, FCPS, FRCP

Role: PRINCIPAL_INVESTIGATOR

Pak Emirates Military Hospital

Locations

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Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Ahsan Tameez Ud Din, MBBS

Role: CONTACT

Phone: (+92 051) 9273480

Email: [email protected]

Facility Contacts

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Ahsan Tameez Ud Din, MBBS

Role: primary

Other Identifiers

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DERM112025

Identifier Type: -

Identifier Source: org_study_id