Diabetic Foot Ulcer Imaging- Study 2

Study Overview
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Brief Summary
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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
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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).

Official Title
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Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging

Conditions
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Foot Ulcer, Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: Ulcer Measurement Software


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |