Status:
WITHDRAWN
Study to Evaluate Bacterial Activity That Drives the Progression of Clinical Infection
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
MedImmune LLC
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
21+ years
Brief Summary
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. Part...
Detailed Description
Study Groups: Participants will be divided 1:1:1 into groups with * Cohort 1: clinically uninfected (1A and 1C) ulcers. * Cohort 2: clinically infected (redness, edema, induration, heat, exudate, te...
Eligibility Criteria
Inclusion
- 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
Exclusion
- • 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03854695
Start Date
February 1 2019
End Date
June 1 2024
Last Update
February 26 2019
Active Locations (1)
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1
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390