Diabetic Foot Ulcer Imaging- Study 2

Not Applicable

Recruiting

• Conditions: Foot Ulcer, Diabetic; Foot Ulcer
• Interventions: Device: Ulcer Measurement Software

• Registration Number: NCT03942081
• Lead Sponsor: Linnea Polgreen

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.

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 Timeline

• Study Start: 2017-09-05
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ulcer Measurement and Photo Group	Ulcer Measurement Software	Diabetic patients with foot ulcers being seen in clinic.

Primary Outcome Measures

Name	Time	Method
Foot Ulcer Size	45 minutes	Size of foot ulcers will be determined by measurement and estimated by software

Secondary Outcome Measures

Name	Time	Method
Quality of Photos: 1 - 5 scale	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.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States