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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 21, 2014
Last verified: April 2014

April 8, 2010
April 21, 2014
December 2004
December 2020   (final data collection date for primary outcome measure)
  • Gene Expression Profiles [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT01101854 on ClinicalTrials.gov Archive Site
Gene Chip Findings [ Time Frame: 1 year or more ] [ Designated as safety issue: No ]
Gene chip findings healing versus non healing wounds.
Not Provided
Composite Subgroup Analyses [ Time Frame: 12 months ] [ Designated as safety issue: No ]

The following groups of patients will be analyzed for common patterns of gene expression using software specifically designed to analyze gene chip results:

  1. Healing vs. non-healing
  2. Age >/= 70 vs. age <70
  3. 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

Not Provided
 
Gene Expression Profiles in Healing and Non-Healing Wounds
Gene Expression Profiles in Healing and Non-Healing Wounds

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.

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 2 to 3 times during a 4-week period at their regularly scheduled wound care visits and debrided tissue (foreign matter and dead tissue from a wound) that is ordinarily discarded will be collected at each sequential visit to build a history of the wound. 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue

Probability Sample

Patients who have a chronic wound(s) (defined as a wound that has been present for at least 4 weeks).

Wounds and Injuries
Not Provided
  • Biopsy Arm
    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.
  • Debridement Arm
    A single subject (current OSU Comprehensive Wound Center patient) will provide debrided tissue sample(s) over a 4-week time period 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1300
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • i. Receiving care at an OSU Comprehensive Wound Center, or one of the additional IRB-approved wound care centers.

Exclusion Criteria:

  • i. Unable to provide informed consent
  • ii. Therapeutically anticoagulated
  • iii. Pregnant females ( > 30 days since 1st day of last menstrual period)
  • iv. Receiving chemotherapy for cancer
Both
18 Years and older
No
Contact: David Paoletto, RN, BA 614-366-3515 david.paoletto@osumc.edu
Contact: Andrea Colcord, RN, MPH 614-366-3515 andrea.colcord@osumc.edu
United States
 
NCT01101854
2004H0278
No
Gayle Gordillo, Ohio State University
Ohio State University
Not Provided
Principal Investigator: Gayle Gordillo, MD Ohio State University
Ohio State University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP