NCT03854695|Withdrawn
Study Stopped
Withdrawing study from PRS-this is not an actual clinical trial
Loading search results
Sponsor study identifier
observational
0
1 country
1
Study Start
February 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2018
Actual (reported)February 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 26, 2019
Actual (reported)January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Assess serum IgG titers
Assess serum IgG titers against our target antigens and host gene expression analysis
Five years
Characterize microbiology
Five years
Characterize immune response
Five years
Assess microbiome
Five years
Cohort 1: clinically uninfected (1A and 1C) ulcers.
Cohort 2: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) with no recent antibiotic therapy (within 28 days)
Cohort 3: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) on antibiotic therapy
Investgator's patients
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
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
Lawrence Lavery, DPM MPH
University of Texas Southwestern Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
December 10, 2018
First Posted
February 26, 2019
Study Start
February 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers
Contact the study team to confirm eligibility.
Primary Completion
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 26, 2019
Record last verified: 2019-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: