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NCT Number: NCT05974982

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

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jinnah Post graduate Medical centre

Karachi, Sindh, 75510, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP

Biological

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.

Conventional Therapy

Other

Conventional therapy

Primary outcomes

  1. Complete healing

    Time frame: 9 months

    Complete healing is defined as 100% epithelialization

  2. Length of ulcer

    Time frame: 9 months

    Length of ulcer in cm at the end of treatment

  3. Width of ulcer

    Time frame: 9 months

    Width of ulcer in cm at the end of treatment

Sponsors and collaborators

Lead sponsor

Jinnah Postgraduate Medical Centre

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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