NCT07211243

Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Lohmann & Rauscher · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 to treatment with either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. The patients who fulfil all other eligibility criteria but have high level of wound exudation will enter a 7-days run-in period, during which they will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored compression therapy with Rosidal® 1C. During the run-in period they should receive appropriate treatment including systemic antimicrobial drug therapy if required. After this time, these patients should be re-assessed and in case they still fulfil all eligibility criteria, and the exudation decreased at least to a moderate level, they will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. In case the exudation would not decrease within this period or other eligibility criteria are not met anymore, they will be screened out. Upon randomisation, all patients will receive the assigned dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also continue to receive adequate compression and, if necessary, systemic antimicrobial drug therapy. During the study participation, selected parameters of the wound will be assessed at Baseline, Interim Visit, and EOT visit. In addition, dressing changes may be performed in-between on as needed basis. After 3 weeks of treatment with Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB, all patients will complete the study. Their further treatment (if necessary), will not be the part of the study.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)	Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
DEVICE	PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)	Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.

Timeline

• Start date: 2025-09-23
• Primary completion: 2026-10-15
• Completion: 2027-06-15
• First posted: 2025-10-07
• Last updated: 2026-04-01

Locations

9 sites across 1 country: Poland