Observational Study: Non-Invasive Testing for Diabetic Foot Ulcer Healing

This study is looking at a device called SnapshotNIR (Kent Imaging) to see how well it can predict wound healing, flap survival, and how high an amputation might need to be in people with diabetic foot ulcers. The SnapshotNIR device measures oxygen levels in the skin without touching it. Researchers want to see if these measurements can help predict how wounds will heal over three years. You might be able to join if you are 18-89 years old, have diabetes, and have moderate to severe diabetic foot ulcers or infections. The study is currently unclear on its recruitment status, but plans to enroll up to 700 participants.

Study design
This is an observational study with no specified phase, meaning participants will receive standard care while researchers collect data. Up to 700 people are planned to be enrolled.
What's involved
If you have a diabetic foot ulcer, your lower extremity will be imaged before, during (if possible), and after surgeries, and monthly for up to six months or until the wound heals. If you are a healthy volunteer, you will have one-time imaging and data collection.
Compensation
Not stated in the trial record.
Follow-up
For participants with diabetic foot ulcers, data will be collected for up to three years to evaluate wound healing.

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NCT04232631

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Recruiting
Not specifiedAges 18–89Observational
University of Texas Southwestern Medical Center
~700 participants
Updated 2025-08-13 on ClinicalTrials.gov
What's tested:SnapshotNIR, Kent Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Three years
Diabetic Foot Ulcer
1 sites across 1 states
Texas1
  • Andrew P Crisologo, DPM · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

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

Exclusion

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
Foot wounds
Non-English speaking
  • 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.Three years

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