Mechanisms Regulating Wound Vascularization
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Mechanisms Regulating Wound Vascularization|
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737321
|United States, Ohio|
|OSU Comprehensive Wound Care Center Morehouse|
|Columbus, Ohio, United States, 43221|
|OSU East Wound Care Center|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Gayle Gordillo, MD||Ohio State University|