A phase-2, multi-centre, prospective, randomized, standard-of-care plus placebo-controlled, patient and central evaluator blinded, parallel arm, clinical study to evaluate safety, tolerability and efficacy of the recommended phase-2 dose of AUP1602-C in two dosing frequencies as a topical treatment for non-healing neuro-ischemic diabetic foot ulcers

diabetic foot ulcers

Incidence of adverse events (AEs), Proportion of patients, receiving the RP2D of AUP1602-C in one of both dosing frequencies, and placebo achieving complete wound closure within 20 weeks after first IMP (i.e., either AUP1602-C or placebo) administration

Percentage of wound area reduction at 4, 8, 12, 16 and 20 weeks after first IMP (AUP1602-C or placebo) administration, Time to complete wound closure (Timeframe: within 20 weeks after first IMP (AUP1602-C or placebo) administration), Time to >50% wound area reduction (Timeframe: within 20 weeks after first IMP (AUP1602-C or placebo) administration), Time to >75% wound area reduction (Timeframe: within 20 weeks after first IMP (AUP1602-C or placebo) administration), Proportion of patients with complete wound closure (Timeframe: Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration), Proportion of patients with a >50% wound area reduction (Timeframe: Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration), Proportion of patients with a >75% wound area reduction (Timeframe: Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration), Proportion of patients with a target ulcer recurrence (Timeframe: Weeks 8, 12, 16 and 20 after first AUP1602-C/placebo administration, and 6 and 12 Months after last IMP (AUP1602-C or placebo) administration), Percentage of wound volume and depth reduction (Timeframe: Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration), Change from baseline in health-related QoL using the EuroQol-5D (EQ-5D) visual analogue scale (VAS), the EQ-5D utility index, and the Dermatology Life Quality Index (DLQI) score (Timeframe: Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration), Change from baseline in patient’s pain intensity using a numerical rating scale (NRS, ranging from 0 = no pain to 10 = worst imaginable pain) (Timeframe: Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration), Incidence and prevalence of target ulcer related periwound skin maceration events (Timeframe: during run-in period, and Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration), Incidence and prevalence of target ulcer related local wound infection events (Timeframe: during run-in period, Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration, and 6 and 12 Months after last IMP (AUP1602-C or placebo) administration), Incidence of surgical procedures related to the target ulcer (Timeframe: during run-in period, Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration, and 6 and 12 Months after last IMP (AUP1602-C or placebo) administration, Incidence of target ulcer related amputation events (Timeframe: during run-in period, Weeks 4, 8, 12, 16 and 20 after first IMP (AUP1602-C or placebo) administration, and 6 and 12 Months after last IMP (AUP1602-C or placebo) administration), Number of target ulcer related hospital visits during run-in, treatment and post-treatment efficacy and safety follow-up periods, Number of patient-days of target ulcer related antibiotic therapy during run-in, treatment and post-treatment efficacy and safety follow-up periods, Number of patient-days of hospitalization due to complications related to target ulcer during run-in, treatment and post-treatment efficacy and safety follow-up periods

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