Evaluation of ELU42 Topical Spray for the Treatment of 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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Chronic Wound; Open Wound; Wagner Grade 1 - 2
• Intervention / Treatment: Drug: ELU42 Topical Spray

Detailed Description

ELU42 is a small molecule Wnt signaling modulator intended to promote wound healing in chronic diabetic foot ulcers. This early-phase, single-arm, open-label study evaluates safety, systemic exposure indicators, and preliminary efficacy. Subjects receive topical ELU42 for up to six weeks. If a healed wound reopens during Healing Confirmation visits, subjects may restart a full six-week treatment course (maximum 18 applications). Safety assessments include CBC, CMP, ECGs, nutritional markers, and reproductive safety monitoring. Efficacy assessments include Percentage Area Reduction (PAR) and complete wound closure.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Daniel D Holsworth, PhD; Phone Number: 7342550366; Email: dholsworth@eluciderminc.com
• Study Contact Backup: Name: John P Delgado, MD; Phone Number: 5419445883; Email: jdelgado@eluciderminc.com

Study Locations

• United States
  • Illinois
    • O'Fallon, Illinois, United States, 62269
      • Recruiting
      • Gateway Clinical Trials
      • Contact: John Harper, CRC; Phone Number: 618 277 9533; Email: johnharper@podiatry1st.com
      • Principal Investigator: James Anderson, DPM
    • Springfield, Illinois, United States, 62704
      • Recruiting
      • Independent Clincal Research LLC
      • Contact: Kehkashan Arshad, MD; Phone Number: 217 461 4182; Email: karshad@myfootandanklecenter.com
      • Principal Investigator: John Sigle, DPM, FACFAS
  • New Jersey
    • Oradell, New Jersey, United States, 07649
      • Recruiting
      • Curalta Clinical Trials
      • Principal Investigator: Vincent Giacalone, DPM
      • Contact: Vincent Giacalone, DPM; Phone Number: 551 557 3409; Email: vgiacalone@curalta.com
  • Texas
    • McAllen, Texas, United States, 78501
      • Recruiting
      • Futuro Clinical Trials
      • Contact: Jessica Rodriguez; Phone Number: 956 534 6433; Email: jessica@futuroct.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm, open-label treatment with ELU42 topical spray applied to the index diabetic foot ulcer	Drug: ELU42 Topical Spray; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Wound Closure	100% re-epithelialization with no drainage.	week 12

Collaborators and Investigators

• Sponsor: Eluciderm Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Wound Healing; DFU; Chronic Wound; Open Wound; Wagner 1 and 2 Ulcer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot
• Other Study ID Numbers: IND169928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Summary results will be posted per regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No