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.|
|ClinicalTrials.gov Identifier: NCT03942081|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer Foot Ulcer, Diabetic||Device: Ulcer Measurement Software||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Foot Ulcer Size [ Time Frame: 45 minutes ]Size of foot ulcers will be determined by measurement and estimated by software
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03942081
|Contact: Linnea Polgreen, PhD||(319) firstname.lastname@example.org|
|Contact: Shelby L Francis, PhDemail@example.com|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Shelby L Francis, PhD 319-775-0689 firstname.lastname@example.org|
|Principal Investigator:||Linnea Polgreen, PhD||University of Iowa|