NCT07396376 Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
| NCT ID | NCT07396376 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Eluciderm Inc |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-11-10 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07396376 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07396376 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07396376 currently recruiting?
Yes, NCT07396376 is actively recruiting participants. Contact the research team at dholsworth@eluciderminc.com for enrollment information.
Where is the NCT07396376 trial being conducted?
This trial is being conducted at O'Fallon, United States, Springfield, United States, Oradell, United States, McAllen, United States.
Who is sponsoring the NCT07396376 clinical trial?
NCT07396376 is sponsored by Eluciderm Inc. The trial plans to enroll 15 participants.