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NCT04232631 · ClinicalTrials.gov registry record

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

A clinical trial of Diabetic Foot Ulcer, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
700
Enrollment target
1
Study location

NCT04232631 is a study of Diabetic Foot Ulcer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 700 participants, above the 245-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (186% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04232631, a study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
700 participants
Enrollment target
1
Study location

Study Summary

Normal group: We will collect normative data from healthy individuals to include baseline data, screening, and images. Up to 500 people will be enrolled and can include normal healthy volunteers, staff and students/trainees. Data will be collected one time with no follow up. Patient group: We will prospectively collect data using one instrument (camera) (SnapshotNIR, Kent Imaging, Calgary, Alberta, Canada). We will collect non-contact imaging data before surgeries, during surgeries (if feasible), and during follow-up clinic visits. We will collect vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement, off-loading, and clinic visits from existing medical records. We will collect lab data such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care. Imaging with this device is research-only.

Conditions Studied

Interventions

  • DEVICE SnapshotNIR, Kent Imaging

Study Locations (1)

Texas

  • UT Southwestern Medical Center at Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 700 participants
Start Date 2021-04-28
Est. Completion 2026-09

What the Registry Record Tells You About NCT04232631

The ClinicalTrials.gov registry entry for NCT04232631 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 245-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (186% higher). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which SnapshotNIR, Kent Imaging is the first listed.

NCT04232631 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04232631 about?

NCT04232631 is a clinical study titled "Non-Invasive Testing to Evaluate Wound Healing in Diabetes". Normal group: We will collect normative data from healthy individuals to include baseline data, screening, and images. Up to 500 people will be enrolled and can include normal healthy volunteers, staff and students/trainees. Data will be collected one time with no follow up. Patient group: We will ...

What is the current status of trial NCT04232631?

This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2021-04-28. Estimated completion is 2026-09.

What conditions does trial NCT04232631 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer.

What interventions are being tested in trial NCT04232631?

The interventions under investigation include: SnapshotNIR, Kent Imaging (DEVICE).

Who is sponsoring clinical trial NCT04232631?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04232631 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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