Chronic Leg Ulcer
Conditions
Keywords
Chronic leg ulcer, Platelet rich fibrin
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.
Interventions
BIOLOGICALPlatelet 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)
Sponsors
Pak Emirates Military Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% improvement in Bates Jensen wound assessment tool (BWAT) score | 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). |
Countries
Pakistan
Contacts
CONTACTAhsan Tameez Ud Din, MBBS
PRINCIPAL_INVESTIGATORProf. Moizza Tahir, MBBS, FCPS, FRCP
Pak Emirates Military Hospital
Outcome results
None listed