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NCT05415683 · ClinicalTrials.gov registry record
Wound Assessment Using Spectral Imaging US
A clinical trial of Diabetes and Diabetic Foot Ulcer, sponsored by SpectralMD.
- Completed
- Registry status
- 400
- Enrollment target
- 11
- Study locations
NCT05415683: Completed study of Diabetes and Diabetic Foot Ulcer, sponsored by SpectralMD.
NCT05415683 is a study of Diabetes and Diabetic Foot Ulcer that has completed, run by SpectralMD. The registered enrollment target is 400 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (87% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05415683, a study of Diabetes and Diabetic Foot Ulcer, has completed, sponsored by SpectralMD.
- COMPLETED
- Registry status
- 400 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
The purpose of this study is to build a database for development and validation of a machine learning (ML) algorithm for diabetic foot ulcer (DFU) healing assessment using images obtained with the Spectral MD DeepView device.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST DV-SSP Imaging
Study Locations (11)
Ohio
- Cutting Edge Research LLC - Circleville
- Gentle Foot Care - Grove City
- Gentle Foot Care - Hilliard
- Foot and Ankle Specialist of Ohio - Mentor
- Worthington Foot and Ankle - Worthington
- Lower Extremity Institute of Research & Therapy (LEIRT) - Youngstown
California
- Surgery of Foot and Ankle - Encino
- New Hope Podiatry Group - Los Angeles
New York
- Northwell Hospital - Lake Success
Tennessee
- University of Tennessee Health Science Center, Wound Care Center @ Regional One - Memphis
Texas
- West Houston Foot and Ankle - Missouri City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2024-08-30 |
What the finished NCT05415683 record still lists
NCT05415683 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which DV-SSP Imaging is the first listed.
NCT05415683 lists 11 locations in 5 states (Ohio, California, New York).
Frequently Asked Questions
What is clinical trial NCT05415683 about?
NCT05415683 is a clinical study titled "Wound Assessment Using Spectral Imaging US". 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 medic...
What is the current status of trial NCT05415683?
This trial is currently completed. The enrollment target is 400 participants. The study started on 2022-06-22. Estimated completion is 2024-08-30.
What conditions does trial NCT05415683 study?
This clinical trial studies the following conditions: Diabetes, Diabetic Foot Ulcer, Diabetic Foot.
What interventions are being tested in trial NCT05415683?
The interventions under investigation include: DV-SSP Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05415683?
This trial is sponsored by SpectralMD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05415683 being conducted?
This trial has 11 study locations across California, New York, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05415683's enrollment target sits among peer trials
400 85th of 338 higher than 250 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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