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Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllEluciderm Inc
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In plain words

What the trial is, and whether it could suit you

ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the treatment of chronic diabetic foot ulcers (DFU). ELU42 combines a tankyrase inhibitor (XAV939) with a novel derivatized hyaluronic acid excipient (DHA77) and is applied as a topical spray to the index ulcer. Fifteen adults with Wagner grade 1-2 diabetic foot ulcers that have been present for at least 4 weeks and up to 52 weeks will be enrolled across up to four U.S. clinical sites. After a 2 week run in period during which standard of care (SOC) is provided (off loading, dressings, and debridement), subjects will receive ELU42 applied on site by trained study staff or the investigator three times per week (Monday, Wednesday, Friday) for six weeks (up to 18 applicat

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18 to โ‰ค75 years; * Diagnosis of type 1 or type 2 diabetes mellitus; * A1C โ‰ค 10 (historical within 2 months accepted); * BMI โ‰ค 36; * Index DFU Wagner grade 1-2 with post debridement area โ‰ฅ1.0 cm2 and โ‰ค8.0 cm2; * Index DFU present for 4-52 weeks; * Index ulcer โ‰ฅ1 cm below malleoli; * Adequate perfusion per ABI/TcPO2/PVR/TBI or Doppler; plantar ulcers off loaded โ‰ฅ14 days prior to treatment; * Ability to consent and attend visits; * Contraception requirements for females of childbearing potential. Exclusion Criteria: * Infected index ulcer or surrounding cellulitis; * Ischemic ulcers; osteomyelitis or exposed bone; * Recent systemic antibiotic requirement for active infection (eligibility after resolution and 7 day washout); * Acute/inactive Charcot preventing off loading; hemoglobin \< 10 g/dL (unless Sponsor approves); * ESRD requiring dialysis; * Recent/planned vascular procedure on target leg within 30 days; * Participation in other IP trials within 30 days; * Active alcohol/substance abuse within 3 months; * Pregnancy or lactation; * Other PI judged exclusions
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What it tests

  • ELU42 Topical Spray
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Where

4 sites
Gateway Clinical Trials
O'Fallon, United States
Independent Clincal Research LLC
Springfield, United States
Curalta Clinical Trials
Oradell, United States
Futuro Clinical Trials
McAllen, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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