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PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers

NCT06281483 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-05

No results posted yet for this study

Summary

To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment.

Conditions

  • Chronic Non-healing Skin Ulcers

Interventions

OTHER

platelet-rich plasma

Under aseptic conditions, 20 mL of whole blood will be withdrawn from each patient and will be collected in the centrifuge tube prefilled with Anticoagulant Citrate Dextrose (1.5 mL each). A two-stage centrifugation process (double-spin method) will be employed for the preparation of PRP. The first spin is at 100 relative centrifugal force (RCF) (g) for 10 min, while the second spin is at 400 RCF for 10 min. PRP will be injected into the base of the ulcer and the surrounding skin. Group A: will receive treatment that will include PRP application, conventional debridement, and dressing coverage. Sessions will be repeated weekly for a maximum of eight sessions.

OTHER

platelet-rich fibrin

20 ml blood will be drawn from each patient by venipuncture under aseptic precautions in four sterile glass tubes of 5-ml capacity without anticoagulant and immediately centrifuged. A single stage centrifugation process, that is (200 g for 8 min), has been found to produce a fibrin clot with the highest platelet and WBC count and highest overall cumulative growth factor yield. Group B: will receive treatment that will include PRF application, conventional debridement, and dressing coverage. Sessions will be repeated weekly for a maximum of eight sessions.

OTHER

Surgical debridement, normal saline washing and dressing coverage

Each patient will receive the same conventional debridement and dressing coverage (After opening the bandage, the ulcer will be irrigated with normal saline and will be prepared for debridement as required to remove dead tissues and hyperkeratotic skin. Then, a second wash with normal saline will be done to remove any debris), but without any PRP nor PRF application.

Sponsors & Collaborators

  • Helwan University

    collaborator OTHER

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • Heba Mahmoud Diab, Professor · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-01-01
Completion
2026-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281483 on ClinicalTrials.gov