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
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Poland
Centrum Medyczne Ultramed
NOT_YET_RECRUITING
Krakow
MelissaMed Poradnia Chirurgiczna
NOT_YET_RECRUITING
Lodz
Mikomed Spółka Z Ograniczoną Odpowiedzialnością
RECRUITING
Lodz
Niepubliczny Zakład Opieki Zdrowotnej Argo Centrum Medyczne
NOT_YET_RECRUITING
Lodz
PP CLINIC Pietrzyk spółka partnerska lekarzy
NOT_YET_RECRUITING
Lublin
SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota
NOT_YET_RECRUITING
Ostróda
Lecran - Centrum Opieki Nad Ranami-Kunickiego
NOT_YET_RECRUITING
Wroclaw
Specjalistyczna Pomoc Medyczna Medservice
NOT_YET_RECRUITING
Zabrze
Contact Information
Primary
Daria Trofimenko, MD
daria.trofimenko@de.lrmed.com
02631996385
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2027-06-15
Participants
Target number of participants: 150
Treatments
Experimental: Suprasorb®X+PHMB Pro
Patients will receive the assigned wound dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also receive adequate compression and, if necessary, systemic antimicrobial drug therapy.
Active_comparator: Suprasorb®X+PHMB
Patients will receive the assigned wound dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also receive adequate compression and, if necessary, systemic antimicrobial drug therapy.
Related Therapeutic Areas
Sponsors
Collaborators: AXCELLANT, Clean Data Labs
Leads: Lohmann & Rauscher