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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MolecuLight i:X Imaging Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Rate | ARM 1 vs. ARM 2
|
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Inclusion Criteria:
Exclusion Criteria:
• Patients categorized as having a maintenance wound
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Male and female subjects presenting with non healing diabetic foot ulcer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ILD Research Centre | Vista | California | 92083 | United States | ||
| Northwell Comprehensive Wound Healing Center and Hyperbarics |
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|
| 5 months |
| Lake Success |
| New York |
| 11042 |
| United States |
| SerenaGroup Monroeville | Monroeville | Pennsylvania | 15146 | United States |