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Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT06111183•Aurealis Oy

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients aged 18 and above
•2. Patients with DM of type 1 or 2 having a glycosylated haemoglobin (HbA1c) of ≤ 11.0% OR 97.0 mmol/mol OR 14.9 mmol/l at randomization undergoing therapy for glycaemic control using available diabetes drugs including insulin
•3. Patients with at least one DFU that fulfils all the following criteria:
•* Non-healing target ulcer defined as ≤ 20.0% reduction in area in response to SoC during the 2-weeks run-in period,
•* Duration: ≥ 4 weeks and ≤ 12 months at screening visit 1,
•* Located either in the plantar or on the dorsum of foot, or at or below the ankle,
•* Ulcer is accessible for administration of IMP and can be completely covered by the primary and secondary dressings,
•* Full-thickness, not involving bone or joints (i.e., University of Texas classification Grade 1A, 1C, 2A, 2C)(5),
•* No clinical signs of active wound infection defined by IDSA/IWGDF criteria(6) or clinical evidence osteomyelitis at randomization (V1),
•* Area of the target ulcer between 1.0-10.0 cm2 after debridement at randomization (V1)
+29 more criteria

Exclusion Criteria

•1. Participating in another clinical study or treatment with another investigational product and/or medical device in the 30 days prior to inclusion in the study or within the 5 half-lives of the investigational product, whichever is longer.
•2. Current or previous (within 30 days prior to start of run-in period) treatment of target ulcer with a treatment that could interfere with wound healing/IMP such as biological agents, growth factors, skin equivalents/substitutes (e.g., Regranex®, Apligraf®, or Dermagraft®), keratinocytes, platelet-rich-plasma, collagen products, blood products, placental products, oxygen therapy, topical steroids.
•3. Current or previous (within 1 week prior to first IMP (AUP1602-C or placebo) dosing) treatment with active wound care agents (e.g., local/topical antibiotics OR antibacterials such as silver, iodine, chlorhexidine) OR systemic antibiotics for any indication.
•4. Current or previous (within 2 weeks prior to first IMP (AUP1602-C or placebo) dosing) use of corticosteroids and immunosuppressants. Treatment with immunosuppressive agents with known therapeutic effects longer than 2 weeks may be considered as exclusion and should be consulted with Medical Monitor/Sponsor.
•5. Known hypersensitivity to any of the components of AUP1602-C or placebo
•6. Ulcer of University of Texas Grade ≥ 3, with deep abscess, sinus track, necrosis or gangrene that cannot be removed by debridement.
•7. Target ulcers with excessive exudation requiring more than one dressing change within 24-hrs.
•8. Target ulcers with clinically significant periwound skin maceration.
•9. Target ulcer with known or suspected active infection, which requires antimicrobials. Any antibiotic therapy must be completed or discontinued within 1 week prior to first IMP (AUP1602-C or placebo) dosing.
•10. Target ulcers requiring urgent vascular surgical interventions.

Locations (10)

Institut für Diabetesforschung Muenster GmbH

Münster, Germany

Hauärztliche und Diabetologische Praxis

Pirna, Germany

Ospedale San Donato

Arezzo, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

AOU Pisana - Ospedale S. Chiara

Pisa, Italy

Ospedale S. Jacopo Pistoia, Diabetologia e Diabetic foot unit Aziendale

Pistoia, Italy

Mikomed

Lodz, Poland

Med-Polonia SP. Z O.O.

Poznan, Poland

PODOS Klinika Leczenia Ran Podema sp. z o.o.

Warsaw, Poland

Lecran Centrum Opieki Nad Ranami

Wroclaw, Poland

Key Dates

Start Date

July 21, 2023

Primary Completion Date

November 28, 2025

Completion Date

November 28, 2025

Last Updated

February 12, 2026

Enrollment

ACTUAL participants

Conditions

Diabetic Foot Ulcer

Interventions

AUP1602-C

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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