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

NCT03854695 | Withdrawn

• 1 other identifier: 052018-055
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Assess serum IgG titers

  Assess serum IgG titers against our target antigens and host gene expression analysis

  Five years

Secondary Outcomes (1)

• Characterize microbiology

  Five years

Other Outcomes (2)

• Characterize immune response

  Five years

• Assess microbiome

  Five years

Study Arms (3)

Cohort 1

Cohort 1: clinically uninfected (1A and 1C) ulcers.

Cohort 2

Cohort 2: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) with no recent antibiotic therapy (within 28 days)

Cohort 3

Cohort 3: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) on antibiotic therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investgator's patients

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• MedImmune LLC: collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 blood samples - one for serum and one collected in PAXgene tubes 5 tissue samples from wound bed of discarded debridement tissue - one frozen, one fixed in formalin, one placed in RNAlater, one fixed for confocal microscopy and one prepped for Scanning Electron Microscopy (SEM) analysis

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Lawrence Lavery, DPM MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: February 26, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

US (1)