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NCT07396376 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Diabetic Foot Ulcer and Open Wound, sponsored by Eluciderm.

Recruiting
Registry status
Phase 1
Development phase
15
Enrollment target
4
Study locations

NCT07396376: Recruiting Phase 1 study of Diabetic Foot Ulcer and Open Wound, sponsored by Eluciderm.

NCT07396376 is a Phase 1 study of Diabetic Foot Ulcer and Open Wound that is actively recruiting participants, run by Eluciderm. The registered enrollment target is 15 participants, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07396376, a Phase 1 study of Diabetic Foot Ulcer and Open Wound, is actively recruiting participants, sponsored by Eluciderm.

RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target
4
Study locations

Study 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.

Primary Outcome

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

Conditions Studied

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

Interventions

  • DRUG ELU42 Topical Spray

Study Locations (4)

Illinois

  • Gateway Clinical Trials - O'Fallon
  • Independent Clincal Research LLC - Springfield

New Jersey

  • Curalta Clinical Trials - Oradell

Texas

  • Futuro Clinical Trials - McAllen

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2025-11-10
Est. Completion 2026-06-01
Phase Phase 1
Eluciderm

1 total trials

What NCT07396376 shows while recruiting

NCT07396376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (94% lower).

The record links to 4 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which ELU42 Topical Spray is the first listed.

NCT07396376 reports a single indexed study location in Illinois, New Jersey, Texas.

Frequently Asked Questions

What is clinical trial NCT07396376 about?

NCT07396376 is a clinical study titled "Evaluation of ELU42 Topical Spray for the Treatment of 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 tankyras...

What is the current status of trial NCT07396376?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-11-10. Estimated completion is 2026-06-01.

What conditions does trial NCT07396376 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer, Open Wound, Chronic Wound, Wagner Grade 1 - 2.

What interventions are being tested in trial NCT07396376?

The interventions under investigation include: ELU42 Topical Spray (DRUG).

Who is sponsoring clinical trial NCT07396376?

This trial is sponsored by Eluciderm, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07396376 being conducted?

This trial has 4 study locations across Illinois, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Diabetic Foot Ulcer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07396376's enrollment target sits among peer trials

15 64th of 67 higher than 3 of 67 other Diabetic Foot Ulcer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07396376

Source: ClinicalTrials.gov NCT07396376, the US trial registry maintained by the National Library of Medicine. NCT07396376 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.