Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02463500 |
| Other study ID # |
18776 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
May 2023 |
Study information
| Verified date |
July 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
