NCT02142426

Brief Summary

The purpose of this study was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 years until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

September 13, 2011

Last Update Submit

November 24, 2015

Conditions

Wound Chronic Draining

Keywords

wound chronic

Outcome Measures

Primary Outcomes (1)

  • Improve selection of systemic antibiotics based on results using molecular diagnostics.

    The study elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds. It evaluated samples from different regions, different types of wounds, different outcomes, and longitudinal data if multiple samples were sent over time from a single individual.

    1 year

Secondary Outcomes (1)

  • 2. Data Collection: The molecular wound cultures have been performed on thousands of patients from around the country. The information from the culture results that were processed were used to compile an antibiogram for a laboratory.

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic wound patients

You may qualify if:

  • Patients with chronic wounds.

You may not qualify if:

  • Patients without chronic wounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

Related Publications (1)

  • Dowd SE, Wolcott RD, Kennedy J, Jones C, Cox SB. Molecular diagnostics and personalised medicine in wound care: assessment of outcomes. J Wound Care. 2011 May;20(5):232, 234-9. doi: 10.12968/jowc.2011.20.5.232.

    PMID: 21647068RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

To pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds

Study Officials

  • Randall D Wolcott, MD

    Southwest Regional Wound Care Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

September 13, 2011

First Posted

May 20, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

US(1)