Suprasorb X+PHMB Pro versus Suprasorb X+PHMB for infected venous leg 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 is a multicenter, open-label, randomized, parallel-group comparison of two PHMB‑impregnated biocellulose dressings in patients with infected venous leg ulcers. Eligible adults with slight to moderate exudation are randomized to receive either Suprasorb X+PHMB Pro (with an added polyethylene film) or Suprasorb X+PHMB for 21 (±2) days or until complete epithelialization, while continuing compression therapy and systemic antibiotics if needed. Patients with high exudation may enter a 7-day run-in using a superabsorbent dressing and monitored compression and are re-assessed for randomization if exudation decreases. Wound parameters are recorded at baseline, an interim visit, and end of treatment, and dressing changes may occur as clinically indicated.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Infected\* venous\*\* leg ulcer
* Slightly to moderately exuding wound\*\*\*
* Patient has signed informed consent

  * as per CDC definition, also TILI score ≥ 5 \*\* ABPI \> 0.8 and \< 1.2 \*\*\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases

Exclusion Criteria:

* Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study
* Wounds with exposed cartilage tissue (hyaline cartilage)
* Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)
* Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)
* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.

Where it's running

• ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń
  Bialystok, Poland Recruiting
• Mikomed Spółka Z Ograniczoną Odpowiedzialnością
  Lodz, Poland Recruiting
• Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne
  Lodz, Poland Recruiting
• PP CLINIC Pietrzyk spółka partnerska lekarzy
  Lublin, Poland Recruiting
• SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota
  Ostróda, Poland Recruiting
• Lecran - Centrum Opieki Nad Ranami-Kunickiego
  Wroclaw, Poland Recruiting

Study contacts

• Principal investigator: Konrad Pańczak, MD — Lecran - Centrum Opieki Nad Ranami-Kunickiego
• Study coordinator: Daria Trofimenko, MD
• Email: daria.trofimenko@de.lrmed.com
• Phone: 02631996385

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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.