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

Diabetic Foot Ulcer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06111183
Study type Interventional
Source Aurealis Oy
Contact Haritha Samaranayake, MD
Phone +358504384996
Email haritha@aurealistherapeutics.com
Status Recruiting
Phase Phase 2
Start date July 21, 2023
Completion date October 31, 2025
View Details
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