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

NCT05974982 | Completed Phase 1

• 1 other identifier: NO.F.2-81/2022-GENL/249/JPMC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (3)

• Complete healing

  Complete healing is defined as 100% epithelialization

  9 months

• Length of ulcer

  Length of ulcer in cm at the end of treatment

  9 months

• Width of ulcer

  Width of ulcer in cm at the end of treatment

  9 months

Study Arms (2)

Platelet-rich plasma

EXPERIMENTAL

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.

Biological: PRP

Conventional therapy

ACTIVE COMPARATOR

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.

Other: Conventional therapy

Interventions

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.

Platelet-rich plasma

Conventional therapy OTHER

Conventional therapy

Conventional therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 30-80 years of any gender presented with chronic venous leg ulcers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah Post graduate Medical centre

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rabia Ghafoor

  Jinnah Post Graduate Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident dermatologist (fcps)

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 3, 2023
• Study Start: September 1, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-07

Locations

PA (1)