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Mechanisms Regulating Wound Vascularization

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gayle Gordillo, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00737321
First received: August 15, 2008
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

This pilot study is designed to assess the impact of ischemia/ diminished wound vascularization and stress on wound healing by comparing patterns of gene expression in specific cell types critical to wound healing biology, e.g. macrophages or endothelial cells.


Condition Intervention
Wounds and Injuries
Procedure: samples collection will be done.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mechanisms Regulating Wound Vascularization

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Changes in Gene Expression Profile in Healing versus Non-healing Wounds [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Wound tissue biopsies, saliva, serum samples and wound sponges will be obtained at an initial time point, at the midpoint of the study and near the end of wound closure over a 12 week window. If the wound closes quickly, i.e. less than 4 weeks then only 2 biopsies will be obtained.


Biospecimen Retention:   Samples With DNA

All participnts with wounds will have 3 mm punch biopsy performed twice or three times in the whole study period.Obtained tissue sample will be processed immidiately and frozen in liquid nitrogen.The tissue sample will transport to research lab for genomic analysis.


Estimated Enrollment: 80
Study Start Date: August 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2- Diabetics without wound (s)
These group of subject will be controlled arm, included who have good glycemic control Diabetic with HbA1c 8.4 or lower and also with out any open wounds.
Procedure: samples collection will be done.
wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).
1-Subjects with diabetes with wound
This group of subjects will have wound and come for couple of follow up visits for , saliva collection, biopsy collection and blood draw.

Detailed Description:

Chronic wounds affect approximately 2% of the U.S. population at any given time. Animal models can not simulate the complex set of pre-existing conditions in each individual that results in failed wound healing. Therefore, human subjects must be used to obtain valid data. Adequate wound vascularization that permits blood vessels to deliver oxygen to the wound is a requirement for wound healing to occur. This protocol will attempt to gain greater understanding of the mechanisms of chronic wounds through 3 specific aims: 1) identify the angiogenic mechanisms in wound site macrophages, which are required for healing, 2) determine the impact of stress and glucocorticoid resistance on endothelial cell and macrophage biology and ultimately wound healing outcomes, 3) identify patterns of gene expression in wound endothelial cells that are found in healing versus non-healing wounds. This data will be correlated with the wound oxygenation status to determine the impact of wound vascularization on the observed biological responses.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients (n=80)including controlled group will be recruited from the OSU outpatient wound care center located at Morehouse plaza and OSU East, OSU plastic surgery, OSU diabetic clinics.

Criteria

Inclusion Criteria:

  • Age 18-69 years
  • ischemic wound group
  • non-ischemic wound group
  • diabetes with good glycemic control
  • lower extremity wound

Exclusion Criteria:

  • Age greater ≥ 70 years
  • End stage renal disease
  • Unable to provide informed consent
  • Pregnant women
  • Therapeutically anticoagulated
  • Prisoners
  • Periwound TcOM < 25mmHg
  • Spinal cord injury
  • Taking immunosuppressive medications
  • Individuals with current diagnosis of a major psychiatric illness (e.g.schizophrenia,psychosis)
  • Severe protein malnutrition- pre-albumin < 10 mg/dl or albumin < 2 g/dl
  • Diabetes with poor glucose control-defined as hgb A1c > 8.4%
  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: NCT00737321

Locations
United States, Ohio
OSU Comprehensive Wound Care Center Morehouse
Columbus, Ohio, United States, 43221
OSU East Wound Care Center
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Gayle Gordillo
Investigators
Principal Investigator: Gayle Gordillo, MD Ohio State University
  More Information

Publications:
Responsible Party: Gayle Gordillo, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00737321     History of Changes
Other Study ID Numbers: 2008H0051
Study First Received: August 15, 2008
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Impact of ischemia
Impact of stress and
Identify patterns of gene expression

Additional relevant MeSH terms:
Neovascularization, Pathologic
Wounds and Injuries
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014