NCT07211243 Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers
| NCT ID | NCT07211243 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lohmann & Rauscher |
| Condition | Venous Leg Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-09-23 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Konrad Pańczak, MD
PRINCIPAL INVESTIGATOR
LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO
Frequently Asked Questions
Who can join the NCT07211243 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Leg Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211243 currently recruiting?
Yes, NCT07211243 is actively recruiting participants. Contact the research team at daria.trofimenko@de.lrmed.com for enrollment information.
Where is the NCT07211243 trial being conducted?
This trial is being conducted at Bialystok, Poland, Krakow, Poland, Lodz, Poland, Lodz, Poland and 5 additional locations.
Who is sponsoring the NCT07211243 clinical trial?
NCT07211243 is sponsored by Lohmann & Rauscher. The principal investigator is Konrad Pańczak, MD at LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO. The trial plans to enroll 150 participants.