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.
Conditions:
🦠 Diabetic Foot Ulcer
🗓️ Study Start (Actual) 28 April 2021
🗓️ Primary Completion (Estimated) September 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 200
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Dallas, Texas, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to 89 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 July 2019
  • First Submitted that Met QC Criteria 14 January 2020
  • First Posted 18 January 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 July 2023
  • Last Update Posted 24 July 2023
  • Last Verified July 2023