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

Conditions

• Chronic Wound
• Diabetic Foot Ulcer
• Open Wound
• Wagner Grade 1 - 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ELU42 Topical Spray — DRUG
  Topical spray applied per protocol to the index DFU for up to six weeks. Subjects whose wounds reopen during Healing Confirmation visits may restart a full six-week course (maximum 18 applications). Dose volume and application technique per protocol and pharmacy manual.

Study Details

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 applications). Subjects will be followed weekly during treatment and for up to 6 weeks after the final dose; additional Healing Confirmation visits are scheduled if the wound closes to evaluate the subjects over a course of a 3 month period. The study's co-primary objectives are to assess safety (incidence and severity of adverse events and infections) and to measure percent area reduction (PAR) of the index ulcer at Weeks 4 and 6. Efficacy assessments will be performed by the site investigator using direct two axis planimetry and by automated evaluation using the Tissue Analytics platform (surface area, volume, and PAR). Secondary and exploratory assessments include patient reported outcomes (Wound Q and SF 36), frequency of complete wound healing, wound hydration metrics, and pharmacokinetic sampling in a subset of subjects. Contact information for potential participants and referring clinicians is available at each participating site.

Key Dates

Start date

Nov 10, 2025

Status verified

Feb 2026

Primary completion

Jun 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single-arm, open-label treatment with ELU42 topical spray applied to the index diabetic foot ulcer

Primary Outcome Measure

Percentage Area Reduction (PAR) [ Time Frame: week 4 and week 6 ]

Central Contacts

• Daniel D Holsworth, PhD
  7342550366
  [email protected]
• John P Delgado, MD
  5419445883
  [email protected]

Locations (4)

Find similar trials in O'Fallon, IL

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