Gene Expression Profiles in Healing and Non-Healing Wound (WHGS1)

This study is currently recruiting participants.
Verified August 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University
ClinicalTrials.gov Identifier:
NCT01101854
First received: April 8, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of the research is to determine whether there are similar patterns of genes being turned on and/or turned off among people with healing and non-healing wounds.


Condition
Wounds and Injuries

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gene Expression Profiles in Healing and Non-Healing Wound.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Gene expression profiles [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    determined using gene chip. This yields data in the form of relative rates of gene expression.


Secondary Outcome Measures:
  • Gene chip findings. [ Time Frame: 1 year or more. ] [ Designated as safety issue: No ]
    Gene chip findings healing verses non healing wounds.


Biospecimen Retention:   Samples With DNA

Tissue


Estimated Enrollment: 900
Study Start Date: December 2004
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healing verses non-healing
1

Detailed Description:

A single subject will provide 2 tissue samples from a single wound over a 4 week time period and the samples will be categorized as healing versus non-healing responses on the basis of decreased (healing) or increased (non-healing) wound area measurements over the 4-week time period. A chronic wound generally is a wound which shows no signs of significant healing in four weeks or has not healed in eight weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who have chronic wound, wound should be 4 week or more in one place with out heal.

Criteria

Inclusion Criteria:

  • i. receiving care at an OSU wound care center, or additional additional IRB approved wound care centers
  • ii.Informed consent obtained from patient by designated study nurse

Exclusion Criteria:

  • i. can't provide informed consent
  • ii. therapeutically anticoagulated
  • iii. pregnant females ( > 30 days since 1st day of last menstrual period)
  • iv. receiving chemotherapy for cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101854

Contacts
Contact: Urmila S Gnyawali, RN 614-366-3515 urmila.gnyawali@osumc.edu

Locations
United States, Ohio
Comprehensive Wound Center, The Ohio State University Medical Center. Recruiting
Columbus, Ohio, United States, 43221
Contact: Urmila Gnyawali, RN    614-366-3515    urmila.gnyawali@osumc.edu   
Principal Investigator: Gayle Gordillo, MD         
Sub-Investigator: Chandan Sen, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Gayle Gordillo, MD Ohio State University
  More Information

No publications provided

Responsible Party: Gayle Gordillo, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01101854     History of Changes
Obsolete Identifiers: NCT00618189
Other Study ID Numbers: 2004H0278
Study First Received: April 8, 2010
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
gene expression in healing vs non-healing wounds

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014