Diabetic Foot Ulcer Imaging- Study 2

Foot Ulcer, Diabetic Clinical Trial

Official title:

Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03942081
• Other study ID #: 201706725
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: University of Iowa
• Contact: Linnea Polgreen, PhD
• Phone: (319) 384-3024
• Email: linnea-polgreen[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Device:
• Ulcer Measurement Software
Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Linnea Polgreen	Fraternal Order of the Eagles Diabetes Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot Ulcer Size	Size of foot ulcers will be determined by measurement and estimated by software	45 minutes
Secondary	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