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

NCT ID: NCT05974982

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-05-25

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.

Conditions

Venous Leg Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Platelet-rich plasma

Under aseptic precautions 20 ml of venous blood was drawn and added to a test tube containing acid citrate dextrose in a ratio of 9:1 (blood: Acid citrate dextrose), centrifuged at 5000 rpm for 15 min to separate the red blood cells from the platelets and plasma. Then the supernatant and the buffy coat composed of platelets and plasma were collected and centrifuged again at 2000 rpm for 5-10 min. The bottom layer about 1.5 ml was taken and 10% calcium chloride was added (0.3 ml for 1 ml of PRP). Then the activated PRP was applied to the wound after proper surgical debridement and was dressed with a non-absorbent dressing (paraffin gauze). This process was repeated once weekly for 6 weeks.

Group Type: EXPERIMENTAL

PRP

Intervention Type: 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

These patients were treated conservatively by compression using graduated elastic stockings below the knee and dressing using saline and vaseline gauze weekly for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: OTHER

Conventional therapy

Interventions

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 (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor.

Intervention Type: BIOLOGICAL

Conventional therapy

Conventional therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Faiza Inam Siddiqui

Resident dermatologist (fcps)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia Ghafoor

Role: STUDY_DIRECTOR

Jinnah Post Graduate Medical Centre

Locations

Jinnah Post graduate Medical centre

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

NO.F.2-81/2022-GENL/249/JPMC

Identifier Type: -

Identifier Source: org_study_id