Efficacy of Platelet-rich-Fibrin Gel in Patients With Chronic Leg Ulcers
ConditionChronic Leg Ulcer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age35+
SponsorPak Emirates Military Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All male and female patients more than 35 years old with Chronic Leg Ulcers, presenting to the OPD will be included.
Disqualifiers
Patients with clinical signs of infected ulcers, patients in sepsis and immunosuppressed individuals will be excluded.
Trial design
Design model
Single group
Treatments tested in this trial
Platelet rich Fibrin (PRF)
Biological/VaccinePRF 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)
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: PRF groupExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
1 monthsSponsors and contacts
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Source ClinicalTrials.gov