Diabetic Foot Ulcer Imaging- Study 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2026-07-31

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.

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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).

Conditions

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Foot Ulcer Foot Ulcer, Diabetic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Ulcer Measurement and Photo Group

Diabetic patients with foot ulcers being seen in clinic.

Group Type EXPERIMENTAL

Ulcer Measurement Software

Intervention Type DEVICE

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

Healthy Control Group

Patients without foot ulcers being seen in the clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ulcer Measurement Software

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

Intervention Type DEVICE

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.