Using platelet rich fibrin with antibiotics to treat chronic skin ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.