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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: Recruiting study of Diabetic Foot Ulcer, sponsored by University of Texas Southwestern Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the effectiveness of the Kent instrument to measure perfusion to predict wound healing, flap survival and amputation level healing.
Conditions Studied
Interventions
- DEVICE SnapshotNIR, Kent Imaging
Study Locations (1)
Texas
- UT Southwestern Medical Center at Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2026-09 |
What NCT04232631 shows while recruiting
NCT04232631 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 245-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (186% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04232631's enrollment target sits among peer trials
700 3rd of 67 higher than 65 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer 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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