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Mechanisms Regulating Wound Vascularization

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ClinicalTrials.gov Identifier: NCT00737321
Recruitment Status : Unknown
Verified July 2017 by Gayle Gordillo, Ohio State University.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2008
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University

Tracking Information
First Submitted Date August 15, 2008
First Posted Date August 19, 2008
Last Update Posted Date July 24, 2017
Study Start Date August 2008
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2013)
Changes in Gene Expression Profile in Healing versus Non-healing Wounds [ Time Frame: 12 weeks ]
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mechanisms Regulating Wound Vascularization
Official Title Mechanisms Regulating Wound Vascularization
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Wounds and Injuries
Intervention Procedure: Samples will be collected
wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).
Study Groups/Cohorts
  • 2- Diabetics without wound (s)
    These group of subject will be control arm, included who have good glycemic control diabetic with HbA1c 8.4 or lower and also without any open wounds. Samples will be collected.
    Intervention: Procedure: Samples will be collected
  • 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.
Publications * Beckrich K, Aronovitch SA. Hospital-acquired pressure ulcers: a comparison of costs in medical vs. surgical patients. Nurs Econ. 1999 Sep-Oct;17(5):263-71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 28, 2011)
80
Original Estimated Enrollment
 (submitted: August 18, 2008)
40
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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%
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00737321
Other Study ID Numbers 2008H0051
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gayle Gordillo, Ohio State University
Study Sponsor Gayle Gordillo
Collaborators Not Provided
Investigators
Principal Investigator: Gayle Gordillo, MD Ohio State University
PRS Account Ohio State University
Verification Date July 2017