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Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05974982
Enrollment
48
Registered
2023-08-03
Start date
2022-09-01
Completion date
2023-05-25
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcer

Brief summary

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.

Detailed description

Venous ulcers are the most common form of leg ulcers which have a significant impact on quality of life and work productivity. In addition, the costs associated with the long-term care of these chronic wounds are substantial. Conventional therapies such as dressings, surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory healing since these treatments are not able to provide necessary growth factors that can modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple, affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly good results. Since it is an autologous method, it is biocompatible and safe. Data from this would help in establishing it as a treatment of choice, thereby leading to a reduction in cost and benefiting the patient both financially and psychologically. 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, and transforming growth factor. These growth factors are important in modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis during the healing process.

Interventions

BIOLOGICALPRP

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.

OTHERConventional therapy

Conventional therapy

Sponsors

Jinnah Postgraduate Medical Centre
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complete healing9 monthsComplete healing is defined as 100% epithelialization
Length of ulcer9 monthsLength of ulcer in cm at the end of treatment
Width of ulcer9 monthsWidth of ulcer in cm at the end of treatment

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026