PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers
NCT ID: NCT06281483
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
36 participants
INTERVENTIONAL
2024-01-01
2026-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
NCT04065594
Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
NCT03526913
Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds
NCT02307448
Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Diabetic Foot Ulcers
NCT03890172
Platelet Rich Plasma and Diabetic Foot Ulcer
NCT04750837
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PRP / Group A
12 patient
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.
PRF / Group B
12 patient
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.
Group C (the control group)
12 patient
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helwan University
OTHER
Kafrelsheikh University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Aboshabana Hussein Mohamed
Assistant Lecturer of Dermatology and Venereology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heba Mahmoud Diab, Professor
Role: STUDY_CHAIR
Ain Shams University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Badr Hospital - Helwan University and Kafrelseikh University Hospital
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Eman Mohamed Salah, Assistant Prof
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APCs in chronic skin ulcers
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.