Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers

Sponsor
Lohmann & Rauscher
Study ID
NCT07211243
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.

Key Dates

First listed
Oct 7, 2025
Start date
Sep 23, 2025
Status verified
Mar 2026
Primary completion
Oct 15, 2026
Completion
Jun 15, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro) [ Time Frame: 3 weeks ]

Central Contacts

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