Clinical Trials Directory

Trials / Terminated

TerminatedNCT00737321

Mechanisms Regulating Wound Vascularization

Status
Terminated
Phase
Study type
Observational
Enrollment
36 (actual)
Sponsor
Gayle Gordillo · Academic / Other
Sex
All
Age
18 Years – 69 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESamples will be collectedwound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).

Timeline

Start date
2008-08-01
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2008-08-19
Last updated
2021-12-01

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00737321. Inclusion in this directory is not an endorsement.