Non-Invasive Testing to Evaluate Wound Healing in Diabetes

NCT ID: NCT04232631

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2026-09-30

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

SnapshotNIR, Kent Imaging

Intervention Type: DEVICE

Vascular imaging device

Normal healthy volunteers

over 18 years of age have a foot

SnapshotNIR, Kent Imaging

Intervention Type: DEVICE

Vascular imaging device

Interventions

SnapshotNIR, Kent Imaging

Vascular imaging device

Intervention Type: DEVICE

Eligibility Criteria

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

• Over 18
• Have a foot

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

• Foot wounds
• Non-English speaking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Crisologo, DPM

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew P Crisologo, DPM

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Debby Noble

Role: CONTACT

Debby.Noble@UTSouthwestern.edu

2146488686

Facility Contacts

Debby Noble

Role: primary

debby.noble@UTSouthwestern.edu

214-648-8686

Other Identifiers

2018-0386

Identifier Type: -

Identifier Source: org_study_id