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NCT04281992
Treatment of Diabetic Foot Ulcers With AUP1602-C
Phase 1, PHASE2 trial testing AUP1602-C in Diabetic Foot Ulcer in 26 participants. Completed in 20 March 2023.
20 March 2023
Quick facts
| Lead sponsor | Aurealis Oy |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 28 January 2020 |
| Primary completion | 20 March 2023 |
| Estimated completion | 20 March 2023 |
| Sites | 2 locations across Germany, Poland |
Drugs / interventions tested
- AUP1602-C — full drug profile →
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04281992
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AUP1602-C
Trials testing the same drug.
- NCT06111183 — Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY) · Phase 2 · completed
Other recruiting trials for Diabetic Foot Ulcer
Currently open trials in the same condition.
- NCT07161830 — Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers · NA · recruiting
- NCT07396376 — Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers · Phase 1, PHASE2 · recruiting
- NCT07291817 — Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study · NA · recruiting
- NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
- NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers · NA · recruiting
Other Aurealis Oy trials
Trials by the same sponsor.
- NCT06111183 — Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04281992 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aurealis Oy
- Last refreshed: 28 September 2023
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.
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