Overview

This trial is active, not recruiting.

Condition wounds and injuries
Treatment samples collection will be done.
Sponsor Gayle Gordillo
Start date August 2008
End date June 2016
Trial size 80 participants
Trial identifier NCT00737321, 2008H0051

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
These group of subject will be controlled arm, included who have good glycemic control Diabetic with HbA1c 8.4 or lower and also with out any open wounds.
samples collection will be done.
wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).
This group of subjects will have wound and come for couple of follow up visits for , saliva collection, biopsy collection and blood draw.

Primary Outcomes

Measure
Changes in Gene Expression Profile in Healing versus Non-healing Wounds
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

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%

Additional Information

Official title Mechanisms Regulating Wound Vascularization
Principal investigator Gayle Gordillo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Ohio State University.