Diabetic Foot UlcerPhase 1/2NCT07396376
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
A Phase 1/2 study testing ELU42 Topical Spray in people with Diabetic Foot Ulcer and Wagner Grade 1 - 2, run by Eluciderm Inc at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound
- What is being tested?
- ELU42 Topical Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Nov 2025to 1 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- Participation in other IP trials within 30 days;
- Active alcohol/substance abuse within 3 months;
- Pregnancy or lactation;
- Other PI judged exclusions
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Futuro Clinical Trials
McAllen, Texas, 78501
Jessica Rodriguez, 956 534 6433, jessica@futuroct.com
- Recruiting
Gateway Clinical Trials
O'Fallon, Illinois, 62269
John Harper, CRC, 618 277 9533, johnharper@podiatry1st.com
James Anderson, DPM
- Recruiting
Curalta Clinical Trials
Oradell, New Jersey, 07649
Vincent Giacalone, DPM, 551 557 3409, vgiacalone@curalta.com
Vincent Giacalone, DPM
- Recruiting
Independent Clincal Research LLC
Springfield, Illinois, 62704
Kehkashan Arshad, MD, 217 461 4182, karshad@myfootandanklecenter.com
John Sigle, DPM, FACFAS
About this study
Official title: Protocol ELU42 01 01: Phase I/IIA, Open Label, Single Arm Evaluation of Topical ELU42 (XAV939 in DHA77) for Wagner Grade 1-2 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 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.
Read more
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.
Read the detailed description
ELU42 is a small molecule Wnt signaling modulator intended to promote wound healing in chronic diabetic foot ulcers. This early-phase, single-arm, open-label study evaluates safety, systemic exposure indicators, and preliminary efficacy. Subjects receive topical ELU42 for up to six weeks. If a healed wound reopens during Healing Confirmation visits, subjects may restart a full six-week treatment course (maximum 18 applications). Safety assessments include CBC, CMP, ECGs, nutritional markers, and reproductive safety monitoring. Efficacy assessments include Percentage Area Reduction (PAR) and complete wound closure.
- Conditions
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound, Open Wound
- Being tested
- ELU42 Topical Spray
- Keywords
- Wagner 1 and 2 Ulcer, Chronic Wound, DFU, Open Wound, Wound Healing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELU42 Topical SprayDrug
Topical spray applied per protocol to the index DFU for up to six weeks. Subjects whose wounds reopen during Healing Confirmation visits may restart a full six-week course (maximum 18 applications). Dose volume and application technique per protocol and pharmacy manual.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, open-label treatment with ELU42 topical spray applied to the index diabetic foot ulcer | Experimental | Not described Receives: Drug: ELU42 Topical Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Area Reduction (PAR)
Percent change in wound area from baseline to Week 4 and week 6 measured by validated planimetry.
Measured: week 4 and week 6
Secondary outcomes (1)
Complete Wound Closure
100% re-epithelialization with no drainage.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start10 Nov 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eluciderm Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396376
- Sponsor's protocol ID
- IND169928
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Summary results will be posted per regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol ELU42 01 01: Phase I/IIA, Open Label, Single Arm Evaluation of Topical ELU42 (XAV939 in DHA77) for Wagner Grade 1-2 Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07396376
- Acronym / sponsor ID
- IND169928
- Conditions
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound, Open Wound
- Keywords
- Wagner 1 and 2 Ulcer, Chronic Wound, DFU, Open Wound, Wound Healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Eluciderm IncIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ELU42 is a small molecule Wnt signaling modulator intended to promote wound healing in chronic diabetic foot ulcers. This early-phase, single-arm, open-label study evaluates safety, systemic exposure indicators, and preliminary efficacy. Subjects receive topical ELU42 for up to six weeks. If a healed wound reopens during Healing Confirmation visits, subjects may restart a full six-week treatment course (maximum 18 applications). Safety assessments include CBC, CMP, ECGs, nutritional markers, and reproductive safety monitoring. Efficacy assessments include Percentage Area Reduction (PAR) and complete wound closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm, open-label treatment with ELU42 topical spray applied to the index diabetic foot ulcer | Experimental | Drug: ELU42 Topical Spray |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELU42 Topical SprayTopical spray applied per protocol to the index DFU for up to six weeks. Subjects whose wounds reopen during Healing Confirmation visits may restart a full six-week course (maximum 18 applications). Dose volume and application technique per protocol and pharmacy manual. | Drug | Single-arm, open-label treatment with ELU42 topical spray applied to the index diabetic foot ulcer |
Primary outcome
Percentage Area Reduction (PAR)
Time frame: week 4 and week 6
Percent change in wound area from baseline to Week 4 and week 6 measured by validated planimetry.
1 secondary outcome
Complete Wound Closure
Time frame: week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Summary results will be posted per regulatory requirements.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ELU42 Topical Spray in people with Diabetic Foot Ulcer and Wagner Grade 1 - 2, run by Eluciderm Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel D Holsworth, PhD (7342550366, dholsworth@eluciderminc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Area Reduction (PAR) (time frame: week 4 and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.