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

NCT06111183 | Completed Phase 2

• 1 other identifier: AT-W-CLI-2022-04
• Study Type: interventional
• Target: 64
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• Incidence of local and systematic adverse events (AEs)

  Incidence of local and systematic adverse events (AEs) for repeatedly administered AUP1602-C and of the placebo control arm.

  6 weeks

• Incidence of Wound Closure

  Proportion of patients with a target ulcer achieving complete wound closure

  20 weeks

Secondary Outcomes (12)

• To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients

  20 weeks

• To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients

  20 weeks

• To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients

  20 weeks

• To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients

  20 weeks

• To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients

  20 weeks

Study Arms (2)

AUP1602-C

EXPERIMENTAL

AUP1602-C is administered topically during the treatment period.

Biological: AUP1602-C

Placebo

PLACEBO COMPARATOR

Placebo is administered topically during the treatment period.

Other: Placebo

Interventions

AUP1602-C BIOLOGICAL

AUP1602-C is topically applied on chronic wounds and covered by wound dressing.

AUP1602-C

Placebo OTHER

Placebo is topically applied on chronic wounds and covered by wound dressing.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 and above
• 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
• 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)
• Ulcer and periwound tissue suitable for application of film dressings (i.e., no contraindications and sufficient periwound space to hold the dressing).
• Patients with either an ankle brachial index (ABI) ≥ 0.7 OR a toe-brachial index (TBI) ≥ 0.5, AND a toe systolic pressure of at least 50.0 mmHg (or ankle systolic pressure of at least 70.0 mmHg if toe-pressure is not measured) on the foot with the target ulcer.
• Patients with an assessment of the baseline level of neuropathy in the lower limb where the target ulcer is located.
• Patients must be willing to wear off-loading footwear, while ambulating, for the period requested by the Investigator.
• A woman of childbearing potential (WOCBP) must have a negative serum pregnancy test at the time of screening after sign the informed consent and a negative pregnancy dip-stick test at baseline (before starting treatment).

You may not qualify if:

• 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.
• 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.
• Known hypersensitivity to any of the components of AUP1602-C or placebo
• Ulcer of University of Texas Grade ≥ 3, with deep abscess, sinus track, necrosis or gangrene that cannot be removed by debridement.
• Target ulcers with excessive exudation requiring more than one dressing change within 24-hrs.
• Target ulcers with clinically significant periwound skin maceration.
• 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.
• Target ulcers requiring urgent vascular surgical interventions.
• Serum creatinine level of \> 3.0 times the upper limit of normal (ULN).
• Prior radiation therapy (within 6 weeks prior to first IMP (AUP1602-C or placebo) dosing) of any part of the foot/leg bearing the target ulcer under study or total body irradiation.
• Sickle-cell diseases, Reynaud's, or other peripheral vascular disease including venous leg ulcers or any vasculitic ulcer irrespective of the cause will be excluded.
• Active or unstable Charcot deformity of the study foot (i.e., foot is erythematous, warm, oedematous, and is actively remodelling).
• Patients with other reasons for wound healing disturbances: e.g., bleeding disorders, vitamin K deficiency, hypocalcaemia, major immune deficiencies.
• Haemoglobin of less than 8.5 g/dL
• Liver transaminase \& total bilirubin levels greater than 3 times ULN.

Sponsors & Collaborators

• Aurealis Oy: lead

Study Sites (10)

Institut für Diabetesforschung Muenster GmbH

Münster, Germany

Location

Hauärztliche und Diabetologische Praxis

Pirna, Germany

Location

Ospedale San Donato

Arezzo, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Location

AOU Pisana - Ospedale S. Chiara

Pisa, Italy

Location

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

Pistoia, Italy

Location

Mikomed

Lodz, Poland

Location

Med-Polonia SP. Z O.O.

Poznan, Poland

Location

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

Warsaw, Poland

Location

Lecran Centrum Opieki Nad Ranami

Wroclaw, Poland

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This phase 2 study is patient and central evaluator (of wound images) blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 1, 2023
• Study Start: July 21, 2023
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); PL (4); IT (4)