Mechanisms Regulating Wound Vascularization

Wounds and Injuries Clinical Trial

Official title:

Mechanisms Regulating Wound Vascularization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737321
• Other study ID #: 2008H0051
• Status: Terminated
• Start date: August 2008
• Est. completion date: December 2018

Study information

• Verified date: November 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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%

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Wounds and Injuries

Intervention

Procedure:
• Samples will be collected
wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).

Locations

Country	Name	City	State
United States	OSU Comprehensive Wound Care Center Morehouse	Columbus	Ohio
United States	OSU East Wound Care Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Gayle Gordillo

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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