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NCT Number: NCT07294521

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.

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Key information

Conditions

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Ahsan Tameez Ud Din, MBBS

CONTACT

[email protected]

(+92 051) 9273480

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. 50% improvement in Bates Jensen wound assessment tool (BWAT) score

    Time frame: 1 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahsan Tameez Ud Din, MBBS

CONTACT

[email protected]

(+92 051) 9273480

Sponsors and collaborators

Lead sponsor

Pak Emirates Military Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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