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

NCT06281483 | Recruiting

• 1 other identifier: APCs in chronic skin ulcers
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Objective assessment of ulcer size for effectiveness, using Image J software.

  Photographs will be obtained at baseline, one month after and at end of eight sessions (two months) with a Nikon D3300 AF-P 18-55 VR 24.2 Megapixels® digital camera and will be standardized for light and distance from the ulcer.

  Four months of follow up after eight sessions of treatment (six months total)

• Pain assessment

  Pain assessment will be done using Visual analogue scale (scale: 0-10).The Visual analogue scale provides a continuous scale for subjective magnitude estimation and consists of a straight line, the limits of which carry a verbal description of each extreme of the pain to be evaluated. The line is usually 10 cm long and vertical. The Visual analogue scale is often used to evaluate the analgesic properties of various treatments and accomplishes this by measuring either pain relief or pain severity.

  Four months of follow up after eight sessions of treatment (six months total)

• Any adverse effects related to treatment modality

  Any adverse effects related to therapy will be recorded immediately at each sitting and statistically analyzed for comparison between groups of trial.

  Four months of follow up after eight sessions of treatment (six months total)

Study Arms (3)

PRP / Group A

ACTIVE COMPARATOR

12 patient

Other: platelet-rich plasma

PRF / Group B

ACTIVE COMPARATOR

12 patient

Other: platelet-rich fibrin

Group C (the control group)

ACTIVE COMPARATOR

12 patient

Other: Surgical debridement, normal saline washing and dressing coverage

Interventions

platelet-rich plasma OTHER

Under aseptic conditions, 20 mL of whole blood will be withdrawn from each patient and will be collected in the centrifuge tube prefilled with Anticoagulant Citrate Dextrose (1.5 mL each).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.

PRP / Group A

platelet-rich fibrin OTHER

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.

PRF / Group B

Surgical debridement, normal saline washing and dressing coverage OTHER

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.

Group C (the control group)

Eligibility Criteria

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

You may qualify if:

• Patients presenting with cutaneous ulcers greater than six weeks of duration and a size ranging between 0.5 and 10 cm, having a normal platelet count and hemoglobin \>10 gm%.

You may not qualify if:

• Patients with known bleeding disorders, and/or on oral anticoagulant therapy, uncontrolled diabetes, proven malignancy.
• Patients who are pregnant or lactating.
• Patients with actively infected ulcers, clinically defined by purulent discharge, green discoloration or fever, or positive culture, ulcers with exposed bone with no underlying granulation tissue, HIV, HCV, HBV patients.
• Patients who are with unrealistic expectations and unwilling to give consent for treatment or photography.

Sponsors & Collaborators

• Kafrelsheikh University: lead
• Helwan University: collaborator

Study Sites (1)

Badr Hospital - Helwan University and Kafrelseikh University Hospital

Cairo, Egypt

RECRUITING

Related Publications (5)

• Badran Z, Abdallah MN, Torres J, Tamimi F. Platelet concentrates for bone regeneration: Current evidence and future challenges. Platelets. 2018 Mar;29(2):105-112. doi: 10.1080/09537104.2017.1327656. Epub 2017 Jun 26.

  PMID: 28649897 BACKGROUND

• Chen J, Wan Y, Lin Y, Jiang H. Platelet-rich fibrin and concentrated growth factors as novel platelet concentrates for chronic hard-to-heal skin ulcers: a systematic review and Meta-analysis of randomized controlled trials. J Dermatolog Treat. 2022 Mar;33(2):613-621. doi: 10.1080/09546634.2020.1773386. Epub 2020 Jun 1.

  PMID: 32441168 BACKGROUND

• Dashore S, Chouhan K, Nanda S, Sharma A. Platelet-Rich Fibrin, Preparation and Use in Dermatology. Indian Dermatol Online J. 2021 Nov 25;12(Suppl 1):S55-S65. doi: 10.4103/idoj.idoj_282_21. eCollection 2021 Nov.

  PMID: 34976881 BACKGROUND

• Evans AG, Ivanic MG, Botros MA, Pope RW, Halle BR, Glassman GE, Genova R, Al Kassis S. Rejuvenating the periorbital area using platelet-rich plasma: a systematic review and meta-analysis. Arch Dermatol Res. 2021 Nov;313(9):711-727. doi: 10.1007/s00403-020-02173-z. Epub 2021 Jan 12.

  PMID: 33433716 BACKGROUND

• Muthuprabakaran K, Pai VV, Ahmad S, Shukla P. A cross-sectional analysis of the effects of various centrifugation speeds and inclusion of the buffy coat in platelet-rich plasma preparation. Indian J Dermatol Venereol Leprol. 2021 Nov-Dec;87(6):792-799. doi: 10.25259/IJDVL_1050_20.

  PMID: 34245527 BACKGROUND

Study Officials

• Heba Mahmoud Diab, Professor

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Mohamed Aboshabana Hussein, Assistant Lecturer

CONTACT

01007981008; dr.mohamedaboshabana@gmail.com

Eman Mohamed Salah, Assistant Prof

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Dermatology and Venereology

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)