Mechanisms Regulating Wound Vascularization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Changes in Gene Expression Profile in Healing versus Non-healing Wounds
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gayle Gordillo
Professor
Ohio State University