UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository (DFUDatabase)
|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: NCT02463500|
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : October 8, 2018
This will be a continuing, prospective study of diabetic foot ulcers and infections, risk factors and clinical outcomes and a limited data set conducted by the investigator through the establishment of a data and tissue repository in the uT Southwestern Department of Plastic Surgery. in addition, subjects consented for this research will be asked about inclusion in a recruitment database to be used in the recruitment of subjects for future research on diabetic foot complications.
about 250 patients are seen for diabetic foot ulcers and infections each year.
|Condition or disease||Intervention/treatment|
|Diabetic Foot Ulcers Osteomyelitis||Other: DFU|
Subjects will be consented during a scheduled visit for standard care at the Clements University Hospital, UT Southwestern Wound Clinic, Parkland Hospital or the Parkland ASC Wound Clinic. There will be 2 study visits: Baseline and operating room visit. At the time of scheduled procedures or laboratory blood draws (as part of standard of care or SOC), soft tissue (from wound debridement or surgery), and bone if possible (from surgery or bone biopsy) will be obtained for histological sectioning and/or laboratory analysis. Tissue and or bone (surgical waste will be sent to the plastic surgery laboratory for storage and analysis.
Tissues with or without bone will be sent to the clinical pathology core for paraffin/frozen sectioning. Histological sections will be used for immunostaining and laser capture microdissection to evaluate tissue ultrastructure and region /cell specific gene expression analysis. Samples will also be sent to the Research and Testing Laboratory in Lubbock, TX for bacterial analysis and to Dermagenesis, LLC in Pompano Beach, FL for isolation of cellular components from different wound specimens and to define characteristics such as proliferation and migration rates. Bone (surgical waste) will also be sent to the 1st Department of Internal Medicine, Laiko General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece, for isolation of cellular components and cytokine analysis. In case infected bone is collected during surgery, it will be fixed and processed in the imaging core laboratory of our facility to evaluate biofilm with a Scanning Electron Microscope.
Relevant information obtained from the medical record will include age, gender, ethnicity, size (dimensions) of ulcer, location of ulcer, duration of ulcer, results of neurological and vascular testing, medical comorbidities, social history, laboratory data, offloading, and history of prior treatment (limited data set with no personal identifying information). Patient information will be de-identified and assigned a code. Bone and tissue samples will be banked in the UT Southwestern Department of Plastic Surgery Laboratory and tested for bacteria, biomarkers, inflammatory cytokines and other indicators of infection. All samples will be kept under the control of the principal investigator and used until exhausted. We will also follow these subjects for two (2) years to identify incidents of care and hospital readmissions for diabetic foot complications through review of the subject's electronic medical record.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2020|
DFU with/without osteomyelitis
Patients of the investigators. Male and female, age 18 and older (up to age 89), of any race or ethnicities, who have diabetes (Type I or II) and a foot ulceration.
- Wound Healing [ Time Frame: 12 Weeks ]Wound healing defined as fully epithelialized over the base.
- Biomarkers [ Time Frame: 2 Years ]Quantity and types of biomarkers in blood, tissue and bone specimens
- Adverse Events [ Time Frame: 1 Years ]Number and type of adverse events, severity.
Biospecimen Retention: Samples Without DNA
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): NCT02463500
|Contact: Tara Kristoffirstname.lastname@example.org|
|Contact: Debby Nobleemail@example.com|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-9132|
|Contact: Debby Noble 214-648-8686 Debby.firstname.lastname@example.org|
|Principal Investigator: Javier LaFontaine, DPM|
|UT Southwestern Medical Center at Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Javier LaFontaine, DPM 214-645-0544 Javier.LaFontaine@UTSouthwestern.edu|
|Contact: Debby Noble 214-648-8686 email@example.com|
|Principal Investigator:||Javier LaFontaine, DPM||UT Southwestern Medical Center|