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Diabetic Foot Ulcer Imaging- Study 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03942081
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : March 11, 2020
Fraternal Order of the Eagles Diabetes Research Center
Information provided by (Responsible Party):
Linnea Polgreen, University of Iowa

Brief Summary:
All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

Condition or disease Intervention/treatment Phase
Foot Ulcer Foot Ulcer, Diabetic Device: Ulcer Measurement Software Not Applicable

Detailed Description:
The research procedures consist of a) a research assistant measuring the size of the foot ulcer, 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ulcer Measurement and Photo Group
Diabetic patients with foot ulcers being seen in clinic.
Device: Ulcer Measurement Software
Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.

Primary Outcome Measures :
  1. Foot Ulcer Size [ Time Frame: 45 minutes ]
    Size of foot ulcers will be determined by measurement and estimated by software

Secondary Outcome Measures :
  1. Quality of Photos: 1 - 5 scale [ Time Frame: 45 minutes ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03942081

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Contact: Linnea Polgreen, PhD (319) 384-3024
Contact: Shelby L Francis, PhD 319-678-8037

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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Shelby L Francis, PhD    319-775-0689   
Sponsors and Collaborators
Linnea Polgreen
Fraternal Order of the Eagles Diabetes Research Center
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Principal Investigator: Linnea Polgreen, PhD University of Iowa
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Responsible Party: Linnea Polgreen, Associate Professor, Department of Pharmacy Practice and Science / Division of Health Services Research, University of Iowa Identifier: NCT03942081    
Other Study ID Numbers: 201706725
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases