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

February 23, 2024 updated by: Mohamed Abo Shabana Hussein Mohamed, Kafrelsheikh University

Efficacy of Platelet-rich Plasma Versus Platelet-rich Fibrin Versus Conventional Treatment in Chronic Non-healing Skin Ulcers: A Comparative Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An ulcer is a breach in the continuity of skin, epithelium or mucous membrane caused by sloughing out of inflamed necrotic tissue. Chronic ulcers are formed because of the failure in the orderly process that produces anatomic and functional integrity. Ulcers are considered chronic if they show no tendency to heal after six weeks of appropriate treatment or those that have not fully healed after 12 months.

Despite greater understanding of the biology of wound healing over the past 20 years, some chronic wounds, such as venous leg ulcers, pressure ulcers, and diabetic foot ulcers, are recalcitrant to healing.

In addition to local wound-related factors (eg, ischemia, infection) and patient related factors (eg, diabetes, old age, obesity, malnutrition) that can impair healing, reduction in tissue growth factors, an imbalance between proteolytic enzymes and their inhibitors, and the presence of senescent cells seem to be particularly important in chronic wounds.

Regardless of the underlying etiology, non-healing ulcers tend to have chronic pain, discharge, sleep impairment, and subsequent adverse repercussions in quality of life and productivity, and impose a huge economic burden on the medical system.

In the United States, chronic ulcers including decubitus, vascular, inflammatory, and rheumatologic subtypes affect 6 million people, with increasing numbers anticipated in a growing elderly and diabetic populations.

Venous, arterial, and neuropathic ulcers account for up to 90 percent of ulcers. In a survey study in which wound care professionals in Germany reported the etiologies of chronic leg ulcers in over 31,000 patients, venous insufficiency, arterial insufficiency, and mixed venous and arterial insufficiency accounted for 48, 15, and 18 percent of chronic ulcers, respectively. There are multiple less common causes of ulcers, including physical injury, infection, vasculopathy, pyoderma gangrenosum, panniculitis, malignancy, medications.

The characteristics and difficulties in healing chronic ulcers lie in the lack of an adequate blood supply, long-term repeated inflammatory stimulation in the surrounding tissues, and the presence of a dead cavity. For chronic ulcers, the key is to determine the cause, determine the factors that affect the healing process, and create an environment suitable for healing to effectively treat the wound.

Current therapies include debridement, offloading, etc. However, the response to treatment is often poor, and the outcome is disappointing. These wounds place the limb at the risk of infection and amputation and also puts the patients at risk of mortality.

Chronic ulcers are known to have reduced levels of platelet-derived growth factor, basic fibroblast growth factor, epidermal growth factor, and transforming growth factorβ compared with acute wounds. It has been suggested that growth factors may become trapped by extracellular matrix molecules or may be degraded by proteases to an excessive degree, resulting in non-healing.

Many of the growth factors released from platelets play an important role in the wound-healing process, and topical application of concentrated activated platelets can stimulate wound healing in situations where standard wound care treatments are ineffective.

Platelet-rich concentrates, known as autologous platelet concentrates (APCs), have garnered significant attention in recent years and demonstrate remarkable potential in wound treatment.

Previous studies have shown that activated platelets undergo exocytosis of intracellular granules containing growth factors such as platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), and insulin like growth factor (IGF). These growth factors contribute to wound healing by promoting regeneration and wound repair, thereby elucidating the efficacy of APCs therapy in skin regeneration, acne scar treatment, and enhanced wound healing.

APCs can be further classified into platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) based on distinct preparation processes, each with varied clinical applications. PRP, as the first-generation platelet concentrate, is plasma with a high platelet concentration obtained through specific centrifugation of fresh whole blood. PRP contains platelet concentrations four to five times higher than that of whole blood. It has demonstrated positive effects on bone regeneration and wound healing.

PRF, on the other hand, as the second-generation platelet concentrate, exhibits a slow release of growth factors, thereby prolonging their action.

APCs has a greater capacity to modulate the local microenvironment and expedite tissue regeneration. It has also been observed to alleviate pain, accelerate epithelization, and facilitate complete wound healing.

Currently, PRP and PRF, whose therapeutic value is equal to that of stem cells, are currently one of the most promising therapy agents in regenerative medicine. They are increasingly being used in different areas of medicine including aesthetic dermatology, orthopedics, sports medicine and surgery.

Because of the lack of sufficient literature, our study aimed to compare the efficacy of PRP versus PRF versus conventional treatment as a relatively newer modalities in the management of chronic non-healing skin ulcers.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Eman Mohamed Salah, Assistant Prof

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Badr Hospital - Helwan University and Kafrelseikh University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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%.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PRP / Group A
12 patient
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.
Active Comparator: PRF / Group B
12 patient
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.
Active Comparator: Group C (the control group)
12 patient
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective assessment of ulcer size for effectiveness, using Image J software.
Time Frame: Four months of follow up after eight sessions of treatment (six months total)
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
Time Frame: Four months of follow up after eight sessions of treatment (six months total)
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
Time Frame: Four months of follow up after eight sessions of treatment (six months total)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Collaborators

Helwan University

Investigators

  • Study Chair: Heba Mahmoud Diab, Professor, ain shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APCs in chronic skin ulcers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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