Clinical trial NCT00737321: Mechanisms Regulating Wound Vascularization
Official title: Mechanisms Regulating Wound Vascularization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wounds and Injuries
Keywords: Impact of ischemia
Impact of stress and
Identify patterns of gene expression
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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%

Primary outcomes:
measure: Changes in Gene Expression Profile in Healing versus Non-healing Wounds
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OSU East Wound Care Center
state: Ohio
city: Columbus
country: United States
facility: OSU Comprehensive Wound Care Center Morehouse
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gayle Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.