Diabetic Foot Ulcer Imaging- Study 2

Linnea Polgreen

Status: Enrolling

Conditions: Foot Ulcer, Diabetic; Foot Ulcer

Treatments: Device: Ulcer Measurement Software

Study type: Interventional

Funder types: Other

Identifiers

NCT03942081

201706725

Details and patient eligibility

About

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.

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Ulcer Measurement and Photo Group

Experimental group

Description:

Diabetic patients with foot ulcers being seen in clinic.

Treatment:

Device: Ulcer Measurement Software

Healthy Control Group

No Intervention group

Description:

Patients without foot ulcers being seen in the clinic.