Diabetic Foot Ulcer Imaging- Study 2

Overview

All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

Full Title of Study: “Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2024

Detailed Description

The research procedures consist of a) a research assistant measuring the size of the foot ulcer (for ulcer patients), b) patients having pictures of their feet taken with a smart phone under 4 conditions- 1) photos taken by researchers, 2) photos taken by the patient by hand, 3) photos taken by the patient with a selfie stick, and 4) photos taken by a 3rd party (e.g., friend/family member of patient). If the patient is not able to take photographs under any of the conditions, that condition will be excluded. In addition to photos being taken with a smart phone, additional photos will be taken with a thermal camera by the research team to determine if there is a difference in ulcer size depending on type of camera used. It is anticipated that procedures will last between 15 and 45 minutes. There is no long-term follow-up. If a patient returns to the clinic they will be asked if they wish to complete all study procedures again. Once the patient has left the clinic, the research team will check the medical record for: age, sex, race, ethnicity, BMI, co-morbidities, and zip code (to determine if patient lives in an urban or rural location).

Interventions

  • Device: Ulcer Measurement Software
    • Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.

Arms, Groups and Cohorts

  • Experimental: Ulcer Measurement and Photo Group
    • Diabetic patients with foot ulcers being seen in clinic.
  • No Intervention: Healthy Control Group
    • Patients without foot ulcers being seen in the clinic.

Clinical Trial Outcome Measures

Primary Measures

  • Foot Ulcer Size
    • Time Frame: 45 minutes
    • Size of foot ulcers will be determined by measurement and estimated by software

Secondary Measures

  • Quality of Photos: 1 – 5 scale
    • Time Frame: 45 minutes
    • Quality of foot ulcer photos will be quantitatively assessed using a 1 – 5 scale (with 1 being poor focus and lighting and 5 being excellent focus and lighting). These scores will be determined subjectively by multiple researchers and averaged to a single score.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosed with Type 1 or Type 2 Diabetes – Has a current foot lesion – Receiving care through University of Iowa Hospitals and Clinics (UIHC) Iowa River Landing Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic. Exclusion Criteria:

  • Cognitive impairment that prevents consent – Lack of fluency in speaking or understanding English – Known aversion to research studies

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Linnea Polgreen
  • Collaborator
    • Fraternal Order of the Eagles Diabetes Research Center
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Linnea Polgreen, Associate Professor, Department of Pharmacy Practice and Science / Division of Health Services Research – University of Iowa
  • Overall Official(s)
    • Linnea Polgreen, PhD, Principal Investigator, University of Iowa
  • Overall Contact(s)
    • Linnea Polgreen, PhD, (319) 384-3024, linnea-polgreen@uiowa.edu

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