A phase II, randomized, observer-blinded, controlled, parallel group clinical trial with decentralized elements to evaluate the safety and efficacy of PB-TX-01 in patients with chronic wounds colonized by Pseudomonas aeruginosa.

Condition studied

Chronic wound colonized by Pseudomonas aeruginosa

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 90 days, coded using MedDRA and graded according to CTCAE v6.0 (2025)., Reduction of P. aeruginosa bacterial load after 14 days of treatment relative to baseline. Bacterial load will be measured by the presence of colony forming units (CFUs) in bacterial swabs observed after streak plating and categorized into the values “not existent”, “isolated”, “moderate”, “numerous” or “abundant”. Reduction will be defined as “at least one level less” (e.g., from abundant to numerous).

Endpoint detail

Eradication of P. aeruginosa as measured by bacterial swab result (=”not existent”) after 14 days of treatment., Reduction of wound size after 90 days relative to baseline., Mean acute pain of wound treatment (measured through pain visual analogue scale) from Day 1 until Day 14., Reduction of clinical signs of infection (measured by the therapeutic index for local infections (TILI)-score) after 14 days of treatment relative to baseline., Improvement in health status (measured by EQ-5D visual analog scale) on Day 29 relative to baseline., Improvement in disease-specific, health-related quality of life (as measured by the Wound-QoL-17 score) on Day 29 relative to baseline.