Actively Recruiting
Phase I/IIA Open Label Study of ELU42 Topical Spray for Wagner Grade 1-2 Diabetic Foot Ulcers
Led by Eluciderm Inc · Updated on 2026-02-12
15
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ELU42, a topical small molecule combining a tankyrase inhibitor with a special hyaluronic acid, to study its safety and early effects on chronic diabetic foot ulcers. This Phase I/IIA open-label study focuses on adults with Wagner grade 1-2 diabetic foot ulcers lasting between 4 and 52 weeks. The study aims to assess how ELU42 affects wound healing and monitors safety through various health measures. Participants will first receive standard wound care for two weeks, including offloading, dressings, and cleaning. Then, ELU42 topical spray will be applied by trained staff to the ulcer three times a week for six weeks, with up to 18 treatments possible. If the wound heals but later reopens, participants may undergo another six-week treatment course. The study includes weekly visits during treatment and follow-ups for up to six weeks, with additional visits if the wound closes to observe healing over three months. During the study, participants will undergo safety evaluations such as blood tests, heart monitoring, and nutritional assessments. Researchers will measure wound healing by tracking the reduction in ulcer area at weeks 4 and 6 using both manual and automated methods. Secondary assessments include complete wound closure, wound hydration, patient-reported outcomes, and drug level monitoring in some participants. The total participation time includes treatment and follow-up periods up to several months.
CONDITIONS
Brief Title
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 64 75 years
- Diagnosis of type 1 or type 2 diabetes mellitus
- A1C 64 10 (historical within 2 months accepted)
- BMI 64 36
- Index diabetic foot ulcer (DFU) Wagner grade 1-2 with post debridement area between 1.0 and 8.0 cm2
- Index DFU present for 4 to 52 weeks
- Index ulcer located at least 1 cm below the malleoli
- Adequate blood flow to the affected area confirmed by specific tests
- Plantar ulcers off loaded for at least 14 days prior to treatment
- Ability to provide consent and attend study visits
- Contraception for females of childbearing potential
You will not qualify if you...
- Infected index ulcer or surrounding cellulitis
- Ischemic ulcers, osteomyelitis, or exposed bone
- Recent need for systemic antibiotics for active infection (eligible after resolution and 7-day washout)
- Acute or inactive Charcot foot preventing offloading
- Hemoglobin less than 10 g/dL (unless approved by Sponsor)
- End-stage renal disease requiring dialysis
- Recent or planned vascular procedure on target leg within 30 days
- Participation in other investigational product trials within 30 days
- Active alcohol or substance abuse within last 3 months
- Pregnancy or lactation
- Other exclusions as judged by the principal investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks per treatment course, with possible repeats as needed
Participants apply the ELU42 topical spray to their diabetic foot ulcer as directed for up to six weeks. If the wound reopens during Healing Confirmation visits, participants may restart a full six-week treatment course, up to a maximum of 18 applications.
Weekly visits for up to 6 weeks per course
Duration - Up to 6 weeks after last treatment course
Participants are monitored for wound healing status and safety assessments continue, including evaluations of complete wound closure up to week 12.
Visits at week 12 for final assessments
Trial Site Locations
Total: 4 locations
1
Gateway Clinical Trials
O'Fallon, Illinois, United States, 62269
Actively Recruiting
2
Independent Clincal Research LLC
Springfield, Illinois, United States, 62704
Actively Recruiting
3
Curalta Clinical Trials
Oradell, New Jersey, United States, 07649
Actively Recruiting
4
Futuro Clinical Trials
McAllen, Texas, United States, 78501
Actively Recruiting
Research Team
D
Daniel D Holsworth, PhD
J
John P Delgado, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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