Using platelet rich fibrin with antibiotics to treat chronic skin ulcers
Platelet Rich Fibrin in Combination With Topical Antibiotics or Antiseptics in the Treatment of Chronic Wounds - a Prospective, Randomized, Active Controlled, Double Blind Pilot Trial With an Observer-blinded Control Group
This study is testing whether using platelet rich fibrin with or without antibiotics can help people with chronic skin ulcers heal better than standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT02652169 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of platelet rich fibrin (PRF) as a treatment for chronic skin ulcers, comparing its effectiveness both as a standalone therapy and as a carrier for antimicrobial agents. The study is designed with four treatment arms: PRF combined with amikacin and teicoplanin, PRF with a placebo, PRF with PHMB plus Macrogolol, and an active control using Acticoat 7® wound dressing. Patients with infected chronic wounds will be included, and the trial aims to provide evidence for the therapeutic benefits of PRF in wound healing. The study is randomized and controlled, ensuring a rigorous evaluation of the treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic venous ulcers and localized non-systemic soft-tissue infections.
Not a fit: Patients with untreated diabetes, severe peripheral vascular disease, or other complicating infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients with chronic skin ulcers.
How similar studies have performed: While the use of PRF in wound healing is gaining interest, this specific combination with antibiotics is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females aged over 18 who are able to give informed consent * Chronic venous ulcer with localized non-systemic soft-tissue infection diagnosed by senior infectious diseases specialist based on US FDA Guidance for Industry Chronic cutaneous ulcer and burn wounds June 2006: * slough and necrotic tissue * exsudate * smell * inflammation * presence of granulation tissue * pain * Wound size ≥ 5 cm2 and \< 200 cm2 Exclusion Criteria: * Non-treated diabetes mellitus, HbA1c \> 12 mg/dl * Non treated (orthopaedic shoe) diabetic foot syndrome * ABI \< 0,7 * Wound size 15 cm2 and \> 200 cm2 * CRP \> 5 mg/dl * Leucocytes \> 15.000 /μl * Infection of another site * Infection of the ulcer with a pathogen with inherent resistance to amikacin and teicoplanin * Known osteomyelitis * Known erysipelas * Known phlegmon * Complicated deep tissue infection not solely treatable with PRF plus antimicrobial therapy in the opinion of a senior infectious diseases specialist * Planned systemic antimicrobial therapy * Active viral hepatitis (A/B/C) or active HIV infection or active syphilis * Increased sensitivity to amikacin or teicoplanin, PHMB or macrogolol * Increased sensitivity to tramexanic acid or batroxobin * Presence of neoplastic growth in the ulcer * Thrombocytopenic patients (\<150.000 G/L) * Haemoglobin \< 95 g/L * Known pregnancy or lactation * Severe renal impairment (creatinine clearance \<30 ml/min) * History or clinical signs of impairment of the cochlea or vestibularis system * Neuromuscular diseases (i.e. Myasthenia gravis, Parkinson's disease) * Aminoglycoside treatment less than four weeks before inclusion * Other reasons opposing the study participation on the discretion of the investigators
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Florian Thalhammer, Prof. Dr. — Medical University of Vienna
- Study coordinator: Florian Thalhammer, Prof. Dr.
- Phone: 0043140400
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.