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

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05974982
• Other study ID #: NO.F.2-81/2022-GENL/249/JPMC
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: July 2023
• Source: Jinnah Postgraduate Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Biological:
• 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 (aa, aß, aß), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor.

Other:
• Conventional therapy
Conventional therapy

Locations

Country	Name	City	State
Pakistan	Jinnah Post graduate Medical centre	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing	Complete healing is defined as 100% epithelialization	9 months
Primary	Length of ulcer	Length of ulcer in cm at the end of treatment	9 months
Primary	Width of ulcer	Width of ulcer in cm at the end of treatment	9 months