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

Phase 1
Completed
Conditions
Venous Leg Ulcer
Registration Number
NCT05974982
Lead Sponsor
Jinnah Postgraduate Medical Centre
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Complete healing9 months

Complete healing is defined as 100% epithelialization

Length of ulcer9 months

Length of ulcer in cm at the end of treatment

Width of ulcer9 months

Width of ulcer in cm at the end of treatment

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Jinnah Post graduate Medical centre

🇵🇰

Karachi, Sindh, Pakistan

Jinnah Post graduate Medical centre
🇵🇰Karachi, Sindh, Pakistan

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