Diabetic Foot Ulcer Imaging- Study 2

NCT03942081 | Recruiting FDA Device

• 1 other identifier: 201706725
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Ulcer; Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

• Foot Ulcer Size

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

  45 minutes

Secondary Outcomes (1)

• Quality of Photos: 1 - 5 scale

  45 minutes

Study Arms (2)

Ulcer Measurement and Photo Group

EXPERIMENTAL

Diabetic patients with foot ulcers being seen in clinic.

Device: Ulcer Measurement Software

Healthy Control Group

NO INTERVENTION

Patients without foot ulcers being seen in the clinic.

Interventions

Ulcer Measurement Software DEVICE

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

Ulcer Measurement and Photo Group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Linnea Polgreen: lead
• Fraternal Order of the Eagles Diabetes Research Center: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Linnea Polgreen, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linnea Polgreen, PhD

CONTACT

(319) 384-3024; linnea-polgreen@uiowa.edu

Shelby L Francis, PhD

CONTACT

319-678-8037; shelby-francis@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Pharmacy Practice and Science / Division of Health Services Research

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: September 5, 2017
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)