Comparing PRP, PRF, and standard treatment for chronic skin ulcers
Efficacy of Platelet-rich Plasma Versus Platelet-rich Fibrin Versus Conventional Treatment in Chronic Non-healing Skin Ulcers: a Comparative Study
This study is testing if two new treatments for chronic skin ulcers, PRP and PRF, work better than standard care for helping wounds heal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06281483 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two newer treatments, platelet-rich plasma (PRP) and platelet-rich fibrin (PRF), in comparison to conventional methods for managing chronic non-healing skin ulcers. Chronic ulcers are defined as wounds that do not heal within six weeks despite appropriate treatment, affecting millions of individuals, particularly the elderly and diabetic populations. The study will involve patients with ulcers of varying sizes and durations, assessing the healing outcomes of the different treatment modalities. The interventions will include surgical debridement, normal saline washing, and dressing coverage alongside the experimental treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic cutaneous ulcers that have persisted for over six weeks and are between 0.5 and 10 cm in size.
Not a fit: Patients with bleeding disorders, uncontrolled diabetes, active infections, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more effective treatment options for patients suffering from chronic non-healing skin ulcers.
How similar studies have performed: While the use of PRP and PRF in wound healing has shown promise in preliminary studies, this specific comparison against conventional treatments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- Badr Hospital - Helwan University and Kafrelseikh University Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Aboshabana Hussein, Assistant Lecturer
- Email: dr.mohamedaboshabana@gmail.com
- Phone: 01007981008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.