Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04232631
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • SnapshotNIR, Kent Imaging — DEVICE
    Vascular imaging device

Study Details

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.

Key Dates

Start date
Apr 28, 2021
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: patients with diabetic foot ulcers
    * Patient of the investigators * Diagnosis of diabetes mellitus * One or more moderate to severe diabetic foot ulcers/infections * 18-89 years of age
  • Arm: Normal healthy volunteers
    over 18 years of age have a foot

Primary Outcome Measure

Evaluating the effectiveness of SnapshotNIR device to measure perfusion to predict wound healing, flap survival and amputation level healing. The device will report the oxygen saturation, oxyhemoglobin and deoxyhemoglobin levels in superficial tissue. [ Time Frame: Three years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical Center at DallasDallasTexas75390
Debby Noble
[email protected]
214-648-8686

Find similar trials in Dallas, TX

By research site
UT Southwestern Medical Center at Dallas· Dallas, TX

Related Studies