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RecruitingNCT03942081Updated Sep 4, 2026

Diabetic Foot Ulcer Imaging- Study 2

An interventional study of Ulcer Measurement Software in Foot Ulcer and Foot Ulcer, Diabetic, sponsored by Linnea Polgreen. Recruiting at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Linnea Polgreen · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
21 Years to 100 Years
Sex
All
01

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.

Read the 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).

02

Conditions studied

  • Foot Ulcer
  • Foot Ulcer, Diabetic
03

Who can participate

Ages eligible
21 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Cognitive impairment that prevents consent
  • Lack of fluency in speaking or understanding English
  • Known aversion to research studies
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Ulcer Measurement and Photo Group

    Diabetic patients with foot ulcers being seen in clinic.

    Device: Ulcer Measurement Software

  • No intervention
    Healthy Control Group

    Patients without foot ulcers being seen in the clinic.

Interventions

  • DeviceUlcer Measurement Software

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

05

What researchers measure

Primary outcomes

  1. Foot Ulcer Size

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

    Time frame: 45 minutes

Secondary outcomes

  1. Quality of Photos: 1 - 5 scale

    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.

    Time frame: 45 minutes

06

Study locations

1 of 1 sites recruiting
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03942081
Lead sponsor
Linnea Polgreen
Collaborators
Fraternal Order of the Eagles Diabetes Research Center
Responsible party
Linnea Polgreen (Associate Professor, Department of Pharmacy Practice and Science / Division of Health Services Research, University of Iowa) — Sponsor-investigator
First posted
May 8, 2019
Start date
Sep 5, 2017
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Linnea Polgreen, PhD
Contact
linnea-polgreen@uiowa.edu
(319) 384-3024
Shelby L Francis, PhD
Contact
shelby-francis@uiowa.edu
319-678-8037
Linnea Polgreen, PhD
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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