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

NCT02463500 | Completed

• 1 other identifier: 18776
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Foot Ulcers; Osteomyelitis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

DFU OTHER

Standard care.

DFU with/without osteomyelitis

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.-

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Parkland Health and Hospital System: collaborator

Study Sites (2)

UT Southwestern Medical Center

Dallas, Texas, 75390-9132, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

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.

MeSH Terms

Conditions

Diabetic Foot; Osteomyelitis

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Lawrence Lavery, DPM

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Plastic Surgery

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: June 4, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

US (2)