Diabetic Foot Ulcer Imaging- Study 2

Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Foot Ulcer; Foot Ulcer, Diabetic
• Intervention / Treatment: Device: Ulcer Measurement Software

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).

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shelby L Francis, PhD; Phone Number: 319-678-8037; Email: shelby-francis@uiowa.edu
• Study Contact Backup: Name: Linnea Polgreen, PhD; Phone Number: (319) 384-3024; Email: linnea-polgreen@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Shelby L Francis, PhD; Phone Number: 319-775-0689; Email: shelby-francis@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulcer Measurement and Photo Group; Diabetic patients with foot ulcers being seen in clinic.	Device: Ulcer Measurement Software; Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.
No Intervention: Healthy Control Group; Patients without foot ulcers being seen in the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Ulcer Size	Size of foot ulcers will be determined by measurement and estimated by software	45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	45 minutes

Collaborators and Investigators

• Sponsor: Linnea Polgreen
• Collaborators: Fraternal Order of the Eagles Diabetes Research Center
• Investigators: Principal Investigator: Linnea Polgreen, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 201706725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No