Actively Recruiting

Age: 18Years - 89Years
All Genders
Healthy Volunteers
NCT04232631

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Led by University of Texas Southwestern Medical Center · Updated on 2025-08-13

700

Participants Needed

1

Research Sites

278 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Who Can Participate

Age: 18Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient of the investigators
  • Diagnosis of diabetes mellitus
  • One or more moderate to severe diabetic foot ulcers or infections
  • Age between 18 and 89 years
  • Healthy volunteers over 18 years old
  • Healthy volunteers must have a foot
Not Eligible

You will not qualify if you...

  • Non-diabetic individuals
  • Pregnant or planning to become pregnant
  • Nursing or actively lactating
  • Developmental disability or significant psychological disorder that impairs consent or participation
  • Untreated schizophrenia, bipolar disorder, or recent psychiatric hospitalization within 2 years
  • Active alcohol or substance abuse impairing consent or participation
  • History of poor compliance
  • Healthy volunteers with foot wounds
  • Healthy volunteers who are non-English speaking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

D

Debby Noble

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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