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

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

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

Conditions5

Locations4 sites

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