Gene Expression Profiles in Healing and Non-Healing Wound (WHGS1)
This study is currently recruiting participants.
Verified November 2012 by Ohio State University
Sponsor:
Ohio State University
Collaborator:
National Healing Corporation
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University
ClinicalTrials.gov Identifier:
NCT01101854
First received: April 8, 2010
Last updated: November 15, 2012
Last verified: November 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 8, 2010 | ||||
| Last Updated Date | November 15, 2012 | ||||
| Start Date ICMJE | December 2004 | ||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01101854 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gene Expression Profiles in Healing and Non-Healing Wound | ||||
| Official Title ICMJE | Gene Expression Profiles in Healing and Non-Healing Wound. | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Tissue |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients who have chronic wound, wound should be 4 week or more in one place with out heal. |
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| Condition ICMJE | Wounds and Injuries | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Healing verses non-healing
1 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 900 | ||||
| Estimated Completion Date | December 2020 | ||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01101854 | ||||
| Other Study ID Numbers ICMJE | 2004H0278 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gayle Gordillo, Ohio State University | ||||
| Study Sponsor ICMJE | Ohio State University | ||||
| Collaborators ICMJE | National Healing Corporation | ||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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