Recruiting

Wound Healing

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT04232631

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

SnapshotNIR, Kent Imaging

Study Details

Brief 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

Diabetic Foot Ulcer

Study ID

NCT04232631

Start date

Apr 28, 2021

Status verified date

Aug, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Investigator patients

Inclusion Criteria:

  • Patient of the investigators
  • Diagnosis of diabetes mellitus
  • One or more moderate to severe diabetic foot ulcers/infections
  • 18-89 years of age

Exclusion Criteria:

  • Non-diabetic
  • Is pregnant or plans to become pregnant
  • Is nursing or actively lactating
  • Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
  • Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
  • Patients with a history of poor compliance

Normal Healthy volunteers

Inclusion Criteria:

  • Over 18
  • Have a foot

Exclusion Criteria:

  • Foot wounds
  • Non-English speaking

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Normal healthy volunteers

over 18 years of age have a foot

Interventions

SnapshotNIR, Kent Imaging

Vascular imaging device

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 and Locations

Central contacts

Debby Noble

2146488686Debby.Noble@UTSouthwestern.edu

Locations

UT Southwestern Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Debby Noble

214-648-8686debby.noble@UTSouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-08-13.