NCT07396376 · Eluciderm Inc
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
What this study is about
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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 to ≤75 years;
- Diagnosis of type 1 or type 2 diabetes mellitus;
- A1C ≤ 10 (historical within 2 months accepted);
- 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
- O'Fallon, Illinois
- Springfield, Illinois
- Oradell, New Jersey
- McAllen, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations