Diabetic Foot Ulcer Imaging- Study 2
Primary Purpose
Foot Ulcer, Foot Ulcer, Diabetic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulcer Measurement Software
Sponsored by
About this trial
This is an interventional screening trial for Foot Ulcer
Eligibility Criteria
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
Sites / Locations
- University of Iowa Hospitals and ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ulcer Measurement and Photo Group
Healthy Control Group
Arm Description
Diabetic patients with foot ulcers being seen in clinic.
Patients without foot ulcers being seen in the clinic.
Outcomes
Primary Outcome Measures
Foot Ulcer Size
Size of foot ulcers will be determined by measurement and estimated by software
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03942081
First Posted
May 6, 2019
Last Updated
February 16, 2023
Sponsor
Linnea Polgreen
Collaborators
Fraternal Order of the Eagles Diabetes Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03942081
Brief Title
Diabetic Foot Ulcer Imaging- Study 2
Official Title
Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Linnea Polgreen
Collaborators
Fraternal Order of the Eagles Diabetes Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Foot Ulcer, Diabetic
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ulcer Measurement and Photo Group
Arm Type
Experimental
Arm Description
Diabetic patients with foot ulcers being seen in clinic.
Arm Title
Healthy Control Group
Arm Type
No Intervention
Arm Description
Patients without foot ulcers being seen in the clinic.
Intervention Type
Device
Intervention Name(s)
Ulcer Measurement Software
Intervention Description
Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.
Primary Outcome Measure Information:
Title
Foot Ulcer Size
Description
Size of foot ulcers will be determined by measurement and estimated by software
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Quality of Photos: 1 - 5 scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linnea Polgreen, PhD
Phone
(319) 384-3024
Email
linnea-polgreen@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shelby L Francis, PhD
Phone
319-678-8037
Email
shelby-francis@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linnea Polgreen, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelby L Francis, PhD
Phone
319-775-0689
Email
shelby-francis@uiowa.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diabetic Foot Ulcer Imaging- Study 2
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