Foot Ulcer, Diabetic Clinical Trial
Official title:
Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging
NCT number | NCT03942081 |
Other study ID # | 201706725 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 5, 2017 |
Est. completion date | July 2024 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Linnea Polgreen | Fraternal Order of the Eagles Diabetes Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Foot Ulcer Size | Size of foot ulcers will be determined by measurement and estimated by software | 45 minutes | |
Secondary | 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 |
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