ELU42 Topical Spray for Diabetic Foot Ulcers

This study is testing a topical spray called ELU42 for people with diabetic foot ulcers (DFUs). ELU42 is designed to help wounds heal by affecting how cells communicate (Wnt signaling). Researchers want to see if ELU42 is safe and how well it works to reduce the size of DFUs. You might be able to join if you are 18-75 years old, have type 1 or 2 diabetes, and have a DFU that is Wagner grade 1 or 2, between 1 and 8 square centimeters in size, and has been present for 4 to 52 weeks. The main goal is to measure how much the ulcer area shrinks by week 4 and week 6. The study plans to enroll 15 participants, but the current recruitment status is unclear.

Study design
This is an early-phase, single-arm, open-label study, meaning all participants will receive ELU42 and both you and the study team will know what treatment you are getting. It plans to enroll 15 adults.
What's involved
You would apply ELU42 topical spray to your ulcer for up to six weeks. If your wound reopens, you might restart treatment for another six weeks, up to a maximum of 18 applications. You will have safety assessments including blood tests (CBC, CMP), ECGs, and nutritional and reproductive safety monitoring.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome measures how much the ulcer area shrinks at week 4 and week 6.

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NCT07396376

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Eluciderm Inc
~15 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:ELU42 Topical Spray

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage Area Reduction (PAR)
Measured over week 4 and week 6
Diabetic Foot Ulcer
Wagner Grade 1 - 2
Chronic Wound
Open Wound
4 sites across 3 states
Illinois2
New Jersey1
Texas1

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Eligibility criteria

Inclusion

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

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
  • Percentage Area Reduction (PAR)week 4 and week 6

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