Study to Evaluate Bacterial Activity That Drives the Progression of Clinical Infection

Withdrawn before enrolling

Conditions studied: Diabetic Foot Ulcer

In brief

The investigators plan to enroll up to 750 subjects over the course of 5 years. Study duration will be 2 visits over 7 days (+/-3). Participants will be consented and undergo baseline procedures. Participants will be grouped into 1 of 3 groups, based on infection and antibiotic status at screening. Debridement will be performed per standard of care and collection of tissue will be taken from this discarded tissue. A blood draw will be performed at each of these two visits as well. This is for research purposes only. All other data will be obtained from the electronic medical record. All standard of care except for the blood draws.

Key facts

Study ID

NCT03854695

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2019-02-01

Expected to finish

2024-06-01

Last updated by the study team

2019-02-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)
• One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit, however, only one wound per subject will be included.
• Ulcer grade I or II, Stage A-D, according to University of Texas Wound Classification System
• ≥21 years of age or older
• Diagnosis of diabetes mellitus

You may not qualify if…

• • Subject has major immunodeficiency
• Subject is human immunodeficiency virus (HIV)+
• Subject has untreated osteomyelitis
• Subject has active cellulitis
• Subject has active charcot
• Is pregnant or plans to become pregnant
• Is nursing or actively lactating
• Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years
• Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials

Where it is running

• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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