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NCT04281992

Treatment of Diabetic Foot Ulcers With AUP1602-C

Completed Phase 1, PHASE2 Last updated 28 September 2023
What this trial tests

Phase 1, PHASE2 trial testing AUP1602-C in Diabetic Foot Ulcer in 26 participants. Completed in 20 March 2023.

Timeline
28 January 2020
Primary endpoint
20 March 2023
20 March 2023

Quick facts

Lead sponsorAurealis Oy
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposetreatment
Enrollment26
Start date28 January 2020
Primary completion20 March 2023
Estimated completion20 March 2023
Sites2 locations across Germany, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Aurealis Oy — full company profile →

Who can join

Adults 18 to 80, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Breakthrough treatments for accelerated wound healing.
    Freedman BR, Hwang C, Talbot S, Hibler B, et al · · 2023 · cited 227× · PMID 37196080 · DOI 10.1126/sciadv.ade7007
  2. Engineered bacteria to accelerate wound healing: an adaptive, randomised, double-blind, placebo-controlled, first-in-human phase 1 trial.
    Öhnstedt E, Vågesjö E, Fasth A, Lofton Tomenius H, et al · · 2023 · cited 26× · PMID 37251631 · DOI 10.1016/j.eclinm.2023.102014
  3. Multi-target gene therapy AUP1602-C to improve healing and quality of life for diabetic foot ulcer patients: a phase I, open-label, dose-finding study.
    Schindler C, Mikosiński J, Mikosiński P, Kärkkäinen HR, et al · · 2024 · cited 9× · PMID 39838970 · DOI 10.1177/20420188241294134
  4. RJX Improves Wound Healing in Diabetic Rats.
    Uckun FM, Orhan C, Tuzcu M, Durmus AS, et al · · 2022 · cited 7× · PMID 35721744 · DOI 10.3389/fendo.2022.874291
  5. Immunomodulatory Mechanisms of Chronic Wound Healing: Translational and Clinical Relevance.
    Riaz M, Iqbal MZ, Klar AS, Biedermann T. · · 2025 · cited 1× · PMID 41127507 · DOI 10.1002/mco2.70378
  6. Microbial allies in skin trauma recovery: from immune modulation to engineered probiotic therapeutics.
    Wang AYL, Aviña AE, Liu YY, Kao HK. · · 2026 · PMID 41550964 · DOI 10.1093/burnst/tkaf068

Verify or expand the search:

Other trials of AUP1602-C

Trials testing the same drug.

Other recruiting trials for Diabetic Foot Ulcer

Currently open trials in the same condition.

Other Aurealis Oy trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04281992.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing