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Gene Expression Profiles in Healing and Non-Healing Wounds (WHGS1)
This study is currently recruiting participants.
Verified by Ohio State University, January 2009
First Received: February 5, 2008   Last Updated: January 6, 2009   History of Changes
Sponsors and Collaborators: Ohio State University
National Healing Corporation
Information provided by: Ohio State University
ClinicalTrials.gov Identifier: NCT00618189
  Purpose

The purpose of the study is to determine wether there are sililar patterns of genes being turned on and/or off among people with healing and non-healing wounds


Condition Phase
Wounds and Injuries
 Phase 0

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort
Official Title: Gene Expression Profiles in Healing and Non-Healing Woun

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Genetic relation in healing vs nonhealing wounds [ Time Frame: 5-12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

tissue


Estimated Enrollment: 900
Study Start Date: June 2005
Estimated Study Completion Date: November 2009
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:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from The Ohio State University Comprehensive Wound Centers. In addition to patients from these wound centers, there are 5 additional centers with local IRB approval to participate in a multi-center research trial.

Criteria

Inclusion criteria:

  • Receiving care at The OSU East or Main wound care center, which is managed by The National Healing Corporation (NHC)
  • Informed consent obtained from patient by designated study nurse

Exclusion Criteria:

  • Unable to provide informed consent
  • therapeutically anticoagulated
  • pregnant females ( > 30 days since 1st day of last menstrual period)
  • receiving chemotherapy for cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618189

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

Locations
United States, Ohio
The Ohio State University Comprehensive Wound Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Urmila Gnyawali, RN     614-688-8457     urmila.gnyawali@osu.edu    
Principal Investigator: Gayle Gordillo, M.D.            
Sponsors and Collaborators
Ohio State University
National Healing Corporation
Investigators
Principal Investigator: Gayle Gordillo MD, Chandan Sen PhD Ohio State University
  More Information

Publications:
1. Meehan M, O'Hara L, Morrison YM. Report on the prevalence of skin ulcers in a home health agency population. Advances in Wound Care. 1999;12:459-467 2. Pieper B, Templin TN, Dobal M, Jacox A. Wound prevalence, types, and treatments in home care. Advances in Wound Care. 1999;12:117-126 3. Gottrup F, Holstein P, Jorgensen B, Lohmann M, Karlsmar T. A new concept of a multidisciplinary wound healing center and a national expert function of wound healing. Archives of Surgery. 2001;136:765-772 4. Coerper S, Wicke C, Pfeffer F, Koveker G, Becker HD. Documentation of 7051 chronic wounds using a new computerized system within a network of wound care centers. Archives of Surgery. 2004;139:251-258 5. Kalani M, Brismar K, Fagrell B, Ostergren J, Jorneskog G. Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care. 1999;22:147-151 6. Grolman RE, Wilkerson DK, Taylor J, Allinson P, Zatina MA. Transcutaneous oxygen measurements predict a beneficial response to hyperbaric oxygen therapy in patients with nonhealing wounds and critical limb ischemia. American Surgeon. 2001;67:1072-1079; discussion 1080 7. Misuri A, Lucertini G, Nanni A, Viacava A, Belardi P. Predictive value of transcutaneous oximetry for selection of the amputation level. Journal of Cardiovascular Surgery. 2000;41:83-87 8. Niinikoski J. Hyperbaric oxygen therapy of diabetic foot ulcers, transcutaneous oxymetry in clinical decision making. Wound Repair & Regeneration. 2003;11:458-461 9. Padberg F, Back T, Thompson P, Hobson R. Transcutaneous oxygen (TcPO2) estimates probability of healing in the ischemic extremity. Journal of Surgical Research. 1996;60:365-369 10. Gordillo GM, Schlanger R, Wallace WA, Bergdall V, Bartlett R, Sen CK. Protocols for topical and systemic oxygen treatments in wound healing. Methods in Enzymology. 2004;381:575-585 11. Patterson JA, Bennett RG. Prevention and treatment of pressure sores. Journal of the American Geriatrics Society. 1995;43:919-927 12. Roy S, Rink C, Khanna S, Phillips C, Baghchi D, BachchiI M, Sen CK. Body Weight and Abdominal Fat Gene Expression Profile in Response to a Novel Hydroxycitric Acid-Based Dietary Supplement. Gene Expression. 2004;11:251-262 13. Roy S, Khanna S, Wallace WA, Lappalainen J, Rink C, Cardounel AJ, Zweier JL, Sen CK. Characterization of perceived hyperoxia in isolated primary cardiac fibroblasts and in the reoxygenated heart. J Biol Chem. 2003;278:47129-47135 14. Roy S, Lado BH, Khanna S, Sen CK. Vitamin E sensitive genes in the developing rat fetal brain: a high-density oligonucleotide microarray analysis. FEBS Letters. 2002;530:17-23 15. Roy S, Khanna S, Bentley K, Beffrey P, Sen C. Functional genomics: high-density oligonucleotide arrays. Methods in Enzymology. 2002;352:in press 16. Liu-Stratton Y, Roy S, Sen CK. DNA microarray technology in nutraceutical and food safety. Toxicology Letters. 2004;150:29-42 17. Eisen M, Spellman P, Brown P, Botstein D. Cluster analysis and genome-wide expression patterns. Proceedings of the national Academy of Science. 1998;95:14863-14868

Responsible Party: The Ohio State University Dept of Surgery ( Gayle Gordillo )
Study ID Numbers: 2004H2078
Study First Received: February 5, 2008
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00618189     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009



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