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Clinical trial

Comparison of the Outcome of Treatment With Autologous Platelet Rich Plasma Versus Conventional Therapy for Patients Presenting With Chronic Venous Leg Ulcers

ID
Name
NO.F.2-81/2022-GENL/249/JPMC
Description
The use of PRP has dramatically increased in the fields of orthopedics, spine surgery, reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other fields. In this experimental study, the treatment outcome of autologous PRP was assessed in comparison to conventional therapy among patients with chronic venous leg ulcers.
Trial arms
Trial start
2022-09-01
Estimated PCD
2023-05-25
Trial end
2023-05-25
Status
Completed
Phase
Early phase I
Treatment
PRP
PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor.
Arms:
Platelet-rich plasma
Conventional therapy
Conventional therapy
Arms:
Conventional therapy
Size
48
Primary endpoint
Complete healing
9 months
Length of ulcer
9 months
Width of ulcer
9 months
Eligibility criteria
Inclusion Criteria: * Patients aged 30-80 years of any gender presented with chronic venous leg ulcers Exclusion Criteria: * Patients with history of peripheral arterial disease. * Patients with history of acute venous thromboembolism. * Patients with platelet count less than 150000. * Patients with history of bleeding disorders. * Patients with history of osteoporosis. * Patients with history of peripheral neuropathy. * Pregnant patients assessed by history and confirmed by dating scan. * Patients with history of congestive cardiac failure, chronic liver disease, asthma, COPD, or stroke.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2023-08-03

1 organization

1 product

1 indication

Organization
Jinnah Postgraduate Medical Centre
Product
PRP
Indication
Venous Leg Ulcer