UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository (DFUDatabase)

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 Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers; Osteomyelitis
• Intervention / Treatment: Other: DFU

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9132
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: DFU; Standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing	Wound healing defined as fully epithelialized over the base.	12 Weeks
Biomarkers	Quantity and types of biomarkers in blood, tissue and bone specimens	2 Years
Adverse Events	Number and type of adverse events, severity.	1 Years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Parkland Health and Hospital System
• Investigators: Principal Investigator: Lawrence Lavery, DPM, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: April 16, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimated): June 4, 2015

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Infections; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Diabetic Foot; Foot Ulcer; Ulcer; Osteomyelitis
• Other Study ID Numbers: 18776