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New treatment option for Diabetic Foot Ulcer
Official title Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT07396376
What this study is testing
What is ELU42 Topical Spray?
ELU42 Topical Spray is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for diabetic foot ulcer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- O'Fallon, Illinois, United States
- Springfield, Illinois, United States
- Oradell, New Jersey, United States
- McAllen, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include O'Fallon, Illinois, United States; Springfield, Illinois, United States; Oradell, New Jersey, United States; McAllen, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.