Diabetic Foot Ulcer Imaging- Study 2

Last updated: August 19, 2024
Sponsor: Linnea Polgreen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Ulcers

Treatment

Ulcer Measurement Software

Clinical Study ID

NCT03942081
201706725
  • Ages 21-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 RiverLanding Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic.

Exclusion

Exclusion Criteria:

  • Cognitive impairment that prevents consent

  • Lack of fluency in speaking or understanding English

  • Known aversion to research studies

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Ulcer Measurement Software
Phase:
Study Start date:
September 05, 2017
Estimated Completion Date:
July 31, 2025

Study 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).

Connect with a study center

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

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