Suprasorb X+PHMB Pro versus Suprasorb X+PHMB for infected venous leg ulcers
Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers
This study will test whether Suprasorb X+PHMB Pro heals infected venous leg ulcers better than Suprasorb X+PHMB in adults with slightly to moderately draining wounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lohmann & Rauscher Industry-sponsored |
| Locations | 9 sites (Bialystok and 8 other locations) |
| Trial ID | NCT07211243 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult patients (≥18 years) with an infected venous leg ulcer meeting CDC/TILI criteria, ABPI >0.8 and <1.2, and with slight to moderate wound exudation (or high exudation that decreases after a 7-day run-in) are ideal candidates.
Not a fit: Patients with exposed cartilage, contraindications to compression therapy, persistent high exudation after run-in, known allergy to dressing components, or participation in interfering trials are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, the Pro dressing could speed wound closure or improve local infection control and exudate management compared with the standard PHMB dressing.
How similar studies have performed: PHMB‑impregnated and biocellulose dressings have shown promise in reducing bacterial load and managing exudate in smaller studies, but direct head‑to‑head randomized data comparing these specific dressing formats are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bialystok and 8 other locations
- ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń — Bialystok, Poland (Recruiting)
- Centrum Medyczne Ultramed — Krakow, Poland (Withdrawn)
- MelissaMed Poradnia Chirurgiczna — Lodz, Poland (Withdrawn)
- 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)
- Specjalistyczna Pomoc Medyczna "Medservice" — Zabrze, 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
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.