RECRUITING

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Quick Facts

Study Start:2021-04-28
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04232631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient of the investigators
  2. * Diagnosis of diabetes mellitus
  3. * One or more moderate to severe diabetic foot ulcers/infections
  4. * 18-89 years of age
  1. * Non-diabetic
  2. * Is pregnant or plans to become pregnant
  3. * Is nursing or actively lactating
  4. * 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.
  5. * 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
  6. * Patients with a history of poor compliance

Contacts and Locations

Study Contact

Debby Noble
CONTACT
2146488686
Debby.Noble@UTSouthwestern.edu

Principal Investigator

Lawrence Lavery, DPM MPH
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Lawrence Lavery, DPM MPH, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

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

Study Start Date2021-04-28
Study Completion Date2025-09

Study Record Updates

Study Start Date2021-04-28
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer