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.
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 2022
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.
- Other: DFU
- Standard care.
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
- Wound Healing
- Time Frame: 12 Weeks
- Wound healing defined as fully epithelialized over the base.
- 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.
Participating in This Clinical Trial
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.- Exclusion Criteria:
- Not meeting Inclusion Criteria.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 89 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Parkland Health and Hospital System
- Provider of Information About this Clinical Study
- Principal Investigator: Javier La Fontaine, Professor, Department of Plastic Surgery – University of Texas Southwestern Medical Center
- Overall Official(s)
- Javier LaFontaine, DPM, Principal Investigator, UT Southwestern Medical Center
- Overall Contact(s)
- Tara Kristof, 214-648-9007, Tara.Kristof@UTSouthwestern.edu
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