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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05974982
Other study ID # NO.F.2-81/2022-GENL/249/JPMC
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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