NCT06111183

Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY)

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 AUP1602-C as Treatment for Non-healing Neuro-ischemic DFU

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Aurealis Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.

Detailed description

This is a phase 2 multi-centre, parallel arm, patient and central evaluator-blinded, randomized, SoC plus placebo-controlled study of the RP2D of AUP1602-C performed in DFU patients with non-healing wounds. The RP2D of AUP1602-C derived from phase 1 study is 2.5 x 10E8 CFU/cm2 ulcer area and is used in this study.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	AUP1602-C	AUP1602-C is topically applied on chronic wounds and covered by wound dressing.
OTHER	Placebo	Placebo is topically applied on chronic wounds and covered by wound dressing.

Timeline

• Start date: 2023-07-21
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2023-11-01
• Last updated: 2026-02-12

Locations

10 sites across 3 countries: Germany, Italy, Poland