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investigator moved institutions and did not transfer study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samples will be collected | Procedure | wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Gene Expression Profile in Healing versus Non-healing Wounds | 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gayle Gordillo, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSU East Wound Care Center | Columbus | Ohio | 43205 | United States | ||
| OSU Comprehensive Wound Care Center Morehouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10711175 | Result | 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. No abstract available. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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.
| Columbus |
| Ohio |
| 43221 |
| United States |