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Wound Assessment Using Spectral Imaging US
NCT05415683 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05415683
The ClinicalTrials.gov registry entry for NCT05415683 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SpectralMD, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05415683 reports 11 study locations spanning 5 distinct geographic areas — top geographies include Ohio, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05415683?
The interventions under investigation include: DV-SSP Imaging (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05415683?
This trial is sponsored by SpectralMD, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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