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

NCT07396376 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IND169928
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Keywords

Wagner 1 and 2 Ulcer; Chronic Wound; DFU; Open Wound; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Percentage Area Reduction (PAR)

  Percent change in wound area from baseline to Week 4 and week 6 measured by validated planimetry.

  week 4 and week 6

Secondary Outcomes (1)

• Complete Wound Closure

  week 12

Study Arms (1)

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

EXPERIMENTAL

Drug: ELU42 Topical Spray

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eluciderm Inc: lead

Study Sites (4)

Gateway Clinical Trials

O'Fallon, Illinois, 62269, United States

RECRUITING

Independent Clincal Research LLC

Springfield, Illinois, 62704, United States

RECRUITING

Curalta Clinical Trials

Oradell, New Jersey, 07649, United States

RECRUITING

Futuro Clinical Trials

McAllen, Texas, 78501, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Daniel D Holsworth, PhD

CONTACT

7342550366; dholsworth@eluciderminc.com

John P Delgado, MD

CONTACT

5419445883; jdelgado@eluciderminc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)