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

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ClinicalTrials.gov Identifier: NCT02463500
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : June 15, 2022
Sponsor:
Collaborator:
Parkland Health and Hospital System
Information provided by (Responsible Party):
Larry Lavery, University of Texas Southwestern Medical Center

Brief 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.


Condition or disease Intervention/treatment
Diabetic Foot Ulcers Osteomyelitis 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 : May 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Wound Healing [ Time Frame: 12 Weeks ]
    Wound healing defined as fully epithelialized over the base.

  2. Biomarkers [ Time Frame: 2 Years ]
    Quantity and types of biomarkers in blood, tissue and bone specimens

  3. Adverse Events [ Time Frame: 1 Years ]
    Number and type of adverse events, severity.


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Tara Kristof 214-648-9007 Tara.Kristof@UTSouthwestern.edu
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9132
Contact: Debby Noble    214-648-8686    Debby.noble@utsouthwestern.edu   
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    debby.noble@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Parkland Health and Hospital System
Investigators
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Principal Investigator: Javier LaFontaine, DPM UT Southwestern Medical Center
Additional Information:

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Responsible Party: Larry Lavery, Professor, Department of Plastic Surgery, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02463500    
Other Study ID Numbers: 18776
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Osteomyelitis
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases