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Wound Assessment Using Spectral Imaging US

NCT05415683 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-11-08

No results posted yet for this study

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

  • Diabetes
  • Diabetic Foot
  • Diabetic Foot Ulcer

Interventions

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.

Sponsors & Collaborators

  • SpectralMD

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2024-06-28
Completion
2024-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05415683 on ClinicalTrials.gov