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Recruiting

NCT Number: NCT04232631

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 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.

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Debby Noble

CONTACT

[email protected]

214-648-8686

About this study

This is a prospective, observational study. All medical and surgical care provided to the patient group will be standard of care.

Patient group: Once a patient is identified as requiring vascular intervention or lower extremity ulceration (includes lower extremity wound of any cause, a surgical incision, a flap or graft) and consent to participation, their lower extremity will be imaged. They will be imaged preop, intraop (if feasible) and on post-op day 1 + or - 7 days if they require surgery and for each surgery related to the ulceration. They will also be imaged once a month in follow up for up to a total of 6 months or healing of the wound, determined by study physician.

Normal group: The normal group will have one-time imaging and data collection.

The Kent instrument does not touch the patient and is being evaluated to measure perfusion to predict wound healing, flap survival and amputation level healing. They are research only and not standard of care, and are not being used to determine care in the patient group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SnapshotNIR, Kent Imaging

Device

Vascular imaging device

Primary outcomes

  1. 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

    To evaluate the effectiveness of the Kent instrument to measure perfusion to predict wound healing, flap survival and amputation level healing.

Study contacts

Contact information is provided by the study sponsor or research team.

Debby Noble

CONTACT

[email protected]

2146488686

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2020
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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