Trials / Completed
CompletedNCT05415683
Wound Assessment Using Spectral Imaging US
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (actual)
- Sponsor
- SpectralMD · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments. Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | DV-SSP Imaging | DeepView utilizes imaging data from DFUs to aid in health care providers' assessment of wound healing potential. It is intended to be used as an aid to health care providers in the management of DFU wounds and not as a standalone prediction device. |
Timeline
- Start date
- 2022-06-22
- Primary completion
- 2024-06-28
- Completion
- 2024-08-30
- First posted
- 2022-06-13
- Last updated
- 2024-11-08
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05415683. Inclusion in this directory is not an endorsement.