CompletedPhase 2

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

Germany, Italy64 participantsStarted 2023-07-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. Patients with more than one ulcer will be included if ulcers are separated by a minimum of 2.0 cm healthy tissue. The largest ulcer fulfilling the inclusion criteria will be selected for the investigational treatment.
✓. 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.
✓. Revascularized patients with an ulcer fulfilling the inclusion criteria can be included 3.0 months after the procedure.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.
✕. 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.
✕. 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.

What they're measuring

Incidence of local and systematic adverse events (AEs)

Timeframe: 6 weeks

Incidence of Wound Closure

Timeframe: 20 weeks

Trial details

NCT IDNCT06111183

SponsorAurealis Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials