Gene Expression Profiles in Healing and Non-Healing Wounds (WHGS1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01101854|
Recruitment Status : Recruiting
First Posted : April 12, 2010
Last Update Posted : July 24, 2017
|Condition or disease|
|Wounds and Injuries|
This study has two arms: 1) the biopsy arm and 2) the debridement arm. The purpose of the biopsy arm 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. The purpose of the debridement arm is to (i) identify the nature of bacterial infection and the genes driving the tissue response to it; and (ii) determine how the biofilm components arrest/paralyze the immune function.
For the biopsy arm, a single subject (current OSU Comprehensive Wound Center patient) will provide 2 tissue samples (3 mm punch biopsy samples collected by a wound care physician) from a single wound over a 4-week time period. The wound 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. The ability to obtain additional measurements from patients' medical records up to 12 weeks after enrollment in the study will confirm the healing or non-healing trajectory of the wound.
For the debridement arm, a single subject (current OSU Comprehensive Wound Center patient) will be seen 1 time at the CWC during their regularly scheduled wound care visits or during your scheduled surgery and debrided tissue (foreign matter and dead tissue from a wound) that is ordinarily discarded will be collected. No additional wound care visits will be required as all study-related visits will happen during regularly scheduled appointments at an OSU Comprehensive Wound Center or in the operating room (OR) (if a patient's physician determines that surgical debridement is required). The ability to obtain additional measurements from patients' medical records up to 12 weeks after enrollment in the study will confirm the healing or non-healing trajectory of the wound. Debrided tissue that is collected will be divided into three parts: A) Necrotic/slough tissue (N); B) Live tissue determined by consistency and pinkish color, but not perfused (LNP); or C) Red perfused tissue (LP). If it is difficult to clearly distinguish between the LNP and LP, the two groups will be combined together. In an effort to identify the infection markers of normal or impaired healing, we plan to create a database that contains pathogen type, gene and protein expression profiles and enzymatic activity from infected human wound specimens.
|Study Type :||Observational|
|Estimated Enrollment :||1300 participants|
|Official Title:||Gene Expression Profiles in Healing and Non-Healing Wounds|
|Study Start Date :||December 2004|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
A single subject (current OSU Comprehensive Wound Center patient) will provide 2 tissue samples (3 mm punch biopsies performed by a wound care physician) from a single wound over a 4-week time period.
A single subject (current OSU Comprehensive Wound Center patient) will provide 1 debrided tissue sample as part of their standard wound care treatment (no new wounds will be created). The subject's wound care physician will perform the debridement during an office visit or in the operating room (OR) during surgical debridement.
- Gene Expression Profiles [ Time Frame: 12 weeks ]Will be determined using gene chip. This yields data in the form of relative rates of gene expression.
- Composite Data for Necrotic and Slough Tissue (N) [ Time Frame: 12 months ]Necrotic and slough tissue (N) will be analyzed for the presence and structure of biofilm, pathogen identification via mass spectrometry and culture. Cultured bacteria will be tested for antibiotic resistance.
- Gene Chip Findings [ Time Frame: 1 year or more ]Gene chip findings healing versus non healing wounds.
- Composite Subgroup Analyses [ Time Frame: 12 months ]
The following groups of patients will be analyzed for common patterns of gene expression using software specifically designed to analyze gene chip results:
- Healing vs. non-healing
- Age >/= 70 vs. age <70
- Diabetic ulcers
i. With neuropathy ii. Without neuropathy d. Pressure sores i. With spinal cord injury ii. Without spinal cord injury e. Venous stasis ulcers f. Autoimmune-mediated ulcers g. Radiation-induced ulcers h. Acute wounds i. Surgical site ii. Traumatic injury iii. Burn
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101854
|Contact: David Paoletto, RN, BAfirstname.lastname@example.org|
|Contact: Amy Hoover, BS||614-366-3515||Amy.email@example.com|
|United States, Ohio|
|Comprehensive Wound Center, The Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States, 43221|
|Contact: David Paoletto, RN, BA 614-366-3515 firstname.lastname@example.org|
|Principal Investigator: Gayle Gordillo, MD|
|Sub-Investigator: Chandan Sen, PhD|
|Sub-Investigator: Richard E. Schlanger, M.D.|
|Principal Investigator:||Gayle Gordillo, MD||Ohio State University|