ELU42 topical spray for chronic Wagner 1–2 diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase I/IIa single-arm study administers ELU42 — a tankyrase inhibitor (XAV939) formulated with a derivatized hyaluronic acid excipient (DHA77) — as a topical spray to adults with Wagner grade 1–2 chronic diabetic foot ulcers. After a 2-week standard-of-care run-in, up to 15 participants across U.S. sites will receive on-site ELU42 three times weekly for six weeks (up to 18 applications), with weekly visits during treatment and six weeks of follow-up. Safety assessments include labs (CBC, CMP), ECGs, systemic exposure indicators, nutritional and reproductive monitoring, while exploratory efficacy endpoints include percentage area reduction and complete wound closure. Healed wounds that reopen may be retreated once and tolerability and any systemic absorption will be tracked throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to ≤75 years;
* Diagnosis of type 1 or type 2 diabetes mellitus;
* A1C ≤ 10 (historical within 2 months accepted);
* BMI ≤ 36;
* Index DFU Wagner grade 1-2 with post debridement area ≥1.0 cm2 and ≤8.0 cm2;
* Index DFU present for 4-52 weeks;
* Index ulcer ≥1 cm below malleoli;
* Adequate perfusion per ABI/TcPO2/PVR/TBI or Doppler; plantar ulcers off loaded ≥14 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

Where it's running

• Gateway Clinical Trials
  O'Fallon, Illinois, United States Recruiting
• Independent Clincal Research LLC
  Springfield, Illinois, United States Recruiting
• Curalta Clinical Trials
  Oradell, New Jersey, United States Recruiting
• Futuro Clinical Trials
  McAllen, Texas, United States Recruiting

Study contacts

• Study coordinator: Daniel D Holsworth, PhD
• Email: dholsworth@eluciderminc.com
• Phone: 7342550366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.