Diabetic Foot Ulcer Imaging- Study 2

ConditionsFoot Ulcer Foot Ulcer, Diabetic

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-100

SponsorLinnea Polgreen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Cognitive impairment that prevents consent

Lack of fluency in speaking or understanding English

Known aversion to research studies

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: Ulcer Measurement and Photo GroupExperimental treatment 1 intervention

Group B: Healthy Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Foot Ulcer Size

Size of foot ulcers will be determined by measurement and estimated by software

Time frame

45 minutes

Secondary outcomes

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.

Time frame

45 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linnea Polgreen

Lead sponsor

University of Iowa

Sponsor institution

Fraternal Order of the Eagles Diabetes Research Center

Collaborator

Source ClinicalTrials.gov

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