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

Protocol ELU42 01 01: Phase I/IIA, Open Label, Single Arm Evaluation of Topical ELU42 (XAV939 in DHA77) for Wagner Grade 1-2 Diabetic Foot Ulcers

This will test whether ELU42 topical spray can help heal chronic Wagner 1–2 diabetic foot ulcers in adults.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eluciderm Inc (Industry-sponsored)
• Locations: 4 sites (O'Fallon, Illinois and 3 other locations)
• Trial ID: NCT07396376 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with type 1 or type 2 diabetes, A1C ≤10, BMI ≤36, and a Wagner grade 1–2 index ulcer present 4–52 weeks with post-debridement area 1–8 cm2 and adequate perfusion are ideal candidates.

Not a fit: Patients with infected or ischemic ulcers, osteomyelitis or exposed bone, end-stage renal disease on dialysis, severe anemia, recent/planned vascular procedures on the target leg, or those unable to attend frequent on-site visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, ELU42 could speed healing and increase closure rates for chronic Wagner 1–2 diabetic foot ulcers, potentially reducing infection and amputation risk.

How similar studies have performed: Wnt-pathway modulation has shown promise in preclinical wound-healing models, but clinical evidence in diabetic foot ulcers is limited and the approach remains largely experimental.

Eligibility criteria

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 this trial is running

O'Fallon, Illinois and 3 other locations

• 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

Conditions Diabetic Foot Ulcer; Wagner Grade 1 - 2; Chronic Wound; Open Wound; Wagner 1 and 2 Ulcer; DFU; Wound Healing