Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03942081

Diabetic Foot Ulcer Imaging- Study 2

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Shelby L Francis, PhD

CONTACT

[email protected]

319-775-0689

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulcer Measurement Software

Device

Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.

Primary outcomes

  1. Foot Ulcer Size

    Time frame: 45 minutes

    Size of foot ulcers will be determined by measurement and estimated by software

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linnea Polgreen, PhD

CONTACT

[email protected]

(319) 384-3024

Shelby L Francis, PhD

CONTACT

[email protected]

319-678-8037

Sponsors and collaborators

Lead sponsor

Linnea Polgreen

Other

Collaborators

  • Fraternal Order of the Eagles Diabetes Research Center

Registry information

Official study title

Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
May 8, 2019
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.