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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
  Purpose

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.


Condition
Wounds and Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Profiles in Healing and Non-Healing Wounds

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 ]
    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.


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


Other Outcome Measures:
  • 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



Biospecimen Retention:   Samples With DNA

Tissue


Estimated Enrollment: 1300
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
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.

Detailed Description:

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.

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101854

Contacts
Contact: David Paoletto, RN, BA 614-366-3515 david.paoletto@osumc.edu
Contact: Andrea Colcord, RN, MPH 614-366-3515 andrea.colcord@osumc.edu

Locations
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    david.paoletto@osumc.edu   
Principal Investigator: Gayle Gordillo, MD         
Sub-Investigator: Chandan Sen, PhD         
Sub-Investigator: Richard E. Schlanger, M.D.         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Gayle Gordillo, MD Ohio State University
  More Information

Additional 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: April 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014