Non Healing Diabetic Foot UlcerWARNCT04207099
Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care
An observational study of Non Healing Diabetic Foot Ulcer, run by MolecuLight Inc. at 3 sites in United States.
Trial summary
This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Healing Diabetic Foot Ulcer
- What is being tested?
- MolecuLight i:X Imaging Device
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Feb 2020to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects presenting with non healing diabetic foot ulcer
Who may be able to join
- Male or female patients presenting with chronic DFU
- The chronic DFU has a surface area that has reduced <25% in the previous 4 weeks1 prior to first study visit
- Patient has been receiving treatment for their DFU for less than 12 weeks.
- The chronic DFU is > 1 cm2 in area and less than 15 cm in length (max. diameter)
- 18 years or older
- Willing and able to make all required study visits
Who cannot join
- • Patients categorized as having a maintenance wound
- Use of skin substitutes or hyperbaric oxygen therapy or surgical intervention
- Treatment with an investigational drug within 1 month of enrolment
- Presents with chronic (>10 mg/kg for >30 days) systemic corticoids before enrolment
- Has ABI <0.5 (measured within 3 months of randomisation)
- Undergoing chemotherapy or is immunocompromised
Show all 9Show fewer
- Diagnosed with Charcot disease or ulcers from electrical, chemical or radiation burns, or presents with collagen vascular disease, ulcer malignancy, untreated osteomyelitis or cellulitis
- Recombinant or autologous growth factors or skin/dermal substitutes within 30 days of enrollment
- Inability or unwillingness to consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwell Comprehensive Wound Healing Center and Hyperbarics
Lake Success, New York, 11042
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
ILD Research Centre
Vista, California, 92083
About this study
Official title: A 12-week, Prospective, Parallel Arm, Randomized Controlled Trial (RCT) Comparing Wound Area Reduction of Non-healing Diabetic Foot Ulcers With MolecuLight i:X Used in Standard of Care Compared to Standard of Care Alone
This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.
- Conditions
- Non Healing Diabetic Foot Ulcer
- Being tested
- MolecuLight i:X Imaging Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLight i:X Imaging DeviceDevice
The MolecuLight i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Patients receive standard of care treatment for their diabetic foot ulcer | |
| ARM 2 | Patients receive MolecuLight i:X guided treatment for their diabetic foot ulcer Receives: Device: MolecuLight i:X Imaging Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1
ARM 2 vs ARM 1 Evaluate change in wound area over 12-week period
Measured: 5 months
Secondary outcomes (1)
Wound Healing Rate
ARM 1 vs. ARM 2
- Evaluate increase in wound healing rate over 12-week period
- Evaluate differences in clinical infection i. time to eradicate an infection ii. incidence of new infection (i.e. infection avoidance)
- Determine if MolecuLight i:X images taken at baseline can predict non-healing wounds, region for debridement and/or wounds at risk of infection (based on fluorescent signatures) at 6 and 12 weeks.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start14 Feb 2020
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Healing 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207099
- Sponsor's protocol ID
- 18-014
- Acronym
- WAR
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2019
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Prospective, Parallel Arm, Randomized Controlled Trial (RCT) Comparing Wound Area Reduction of Non-healing Diabetic Foot Ulcers With MolecuLight i:X Used in Standard of Care Compared to Standard of Care Alone
- ClinicalTrials.gov ID
- NCT04207099
- Acronym / sponsor ID
- WAR / 18-014
- Conditions
- Non Healing Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 20 Dec 2019 (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.
This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | – | –Patients receive standard of care treatment for their diabetic foot ulcer |
| ARM 2 | – | Device: MolecuLight i:X Imaging DevicePatients receive MolecuLight i:X guided treatment for their diabetic foot ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects presenting with non healing diabetic foot ulcer
Key inclusion criteria (6 listed)
- Male or female patients presenting with chronic DFU
- The chronic DFU has a surface area that has reduced <25% in the previous 4 weeks1 prior to first study visit
- Patient has been receiving treatment for their DFU for less than 12 weeks.
- The chronic DFU is > 1 cm2 in area and less than 15 cm in length (max. diameter)
- 18 years or older
Key exclusion criteria (9 listed)
- • Patients categorized as having a maintenance wound
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 |
|---|---|---|
| MolecuLight i:X Imaging DeviceThe MolecuLight i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color. | Device | ARM 2 |
Primary outcome
Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1
Time frame: 5 months
ARM 2 vs ARM 1 Evaluate change in wound area over 12-week period
1 secondary outcome
Wound Healing Rate
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Non Healing Diabetic Foot Ulcer
RecruitingPhase 3
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
Recruiting
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
Diabetic Foot Ulcer
RecruitingPhase 1/2
Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care
Diabetic Foot Ulcer (DFU)
Not yet recruiting
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
Leg Ulcer, Pressure Ulcer (PU)
Not yet recruitingObservational study
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Healing Diabetic Foot Ulcer, run by MolecuLight Inc. at 3 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1 (time frame: 5 months). 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 7 Jul 2026.