NCT04232631

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	SnapshotNIR, Kent Imaging	Vascular imaging device

Timeline

• Start date: 2021-04-28
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2020-01-18
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study