Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Data will be collected with 3 vascular imaging devices (IntraOx Vioptix, Newark, CA; Hyperview, HyperMed Imaging, Memphis, TN; Snapshot NIH, Kent Imaging, Calgary, Alberta, Canada). The wound will be imaged with the 3 devices at index research encounter (this will count as the initial pre-operative imaging if the patient requires surgery), before surgery for interval or additional surgeries, during surgery, and during clinic follow-up (one set of imaging approximately every 3-5 weeks) visits for a maximum follow up time of 12 months or until the wound is documented as healed, whichever occurs first. The investigators will collect data from the medial and lateral angiosomes on the dorsum and plantar aspects of the foot and the anterior and posterior leg. Subject data will be obtained from the patient by oral history and physical exam and the medical records of patients of the investigators: vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement and off-loading. Collection of lab data will be obtained such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care. Imaging with the three devices is research-only and is not standard of care.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: IntraOx Vioptix; Device: Hyperview, HyperMed Imaging; Device: Snapshot NIH, Kent Imaging

Detailed Description

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

Once a patient is identified as having a 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 before, during, and on post-op day 1 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 12 months or healing of the wound, whichever comes first.

The 3 instruments do not touch the patient and are being evaluated on their ability to predict wound healing. They are research only and not standard of care, and are not being used to determine care.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Debby Noble; Phone Number: 2146488686; Email: Debby.Noble@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center at Dallas
      • Contact: Debby Noble; Phone Number: 214-648-8686; Email: debby.noble@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Investgator's patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: IntraOx Vioptix; Vascular imaging device; Device: Hyperview, HyperMed Imaging; Vascular imaging device; Device: Snapshot NIH, Kent Imaging; Vascular imaging device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the effectiveness of 3 devices to measure perfusion to predict wound healing	To evaluate the effectiveness of the Hypermed, Kent and Vioptx instruments to measure perfusion to predict wound healing	Three years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Lawrence Lavery, DPM MPH, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 2018-0386

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No