Efficacy of Platelet-rich-Fibrin Gel in Patients With Chronic Leg Ulcers
Overview
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Pak Emirates Military Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 50% improvement in Bates Jensen wound assessment tool (BWAT) score
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
PRF group
Enrolled patients with chronic leg ulcers who will be administered PRF gel
Intervention: Platelet rich Fibrin (PRF) (Biological)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Ahsan Tameez-ud-din
Registrar Dermatology
Pak Emirates Military Hospital