UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository
Condition: Diabetic Foot Ulcers; Osteomyelitis
MeSH terms: Osteomyelitis; Diabetic Foot; Foot Ulcer; Ulcer
Study type: Observational [Patient Registry]

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): DFU
Intervention type(s): Other
Intervention description(s): Standard care.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      Blood, 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.