Status:
RECRUITING
Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers
Lead Sponsor:
Lohmann & Rauscher
Collaborating Sponsors:
AXCELLANT
Clean Data Labs
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
Detailed Description
During the screening, all patients will be assessed for inclusion and exclusion criteria and wound exudation status. Eligible patients with slight or moderate wound exudation will be randomly assigned...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07211243
Start Date
September 23 2025
End Date
June 15 2027
Last Update
October 7 2025
Active Locations (8)
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1
Centrum Medyczne Ultramed
Krakow, Poland
2
MelissaMed Poradnia Chirurgiczna
Lodz, Poland
3
Mikomed Spółka Z Ograniczoną Odpowiedzialnością
Lodz, Poland
4
Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne
Lodz, Poland