New imaging device could reveal hidden bacteria in diabetic wounds
NCT ID NCT04207099
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This trial tests whether a handheld imaging device, called MolecuLight i:X, can help doctors better treat non-healing diabetic foot ulcers. The device uses a special light to make bacteria in the wound glow, so doctors can clean it more thoroughly. About 40 adults with chronic foot ulcers will be randomly assigned to get either standard care or standard care plus imaging guidance. The main goal is to see if the imaging leads to greater wound shrinkage over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MolecuLight i:X Imaging Device
- What this could lead to
- If it works, this device could help doctors see hidden bacteria in wounds, leading to faster healing and fewer infections for people with diabetic foot ulcers.
- What could go wrong
- This is a small, early-stage trial with only 40 patients, so results may not apply to everyone. The device may not significantly improve healing over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
61 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Apr 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male and female subjects presenting with non healing diabetic foot ulcer
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * • 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 * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ILD Research Centre
Vista, California, 92083, United States
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Northwell Comprehensive Wound Healing Center and Hyperbarics
Lake Success, New York, 11042, United States
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SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146, United States