Mechanisms Regulating Wound Vascularization

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.

Study Overview

• Status: Terminated
• Conditions: Wounds and Injuries
• Intervention / Treatment: Procedure: Samples will be collected

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • OSU East Wound Care Center
    • Columbus, Ohio, United States, 43221
      • OSU Comprehensive Wound Care Center Morehouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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%

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2- Diabetics without wound (s); These group of subject will be control arm, included who have good glycemic control diabetic with HbA1c 8.4 or lower and also without any open wounds. Samples will be collected.	Procedure: Samples will be collected; wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).
1-Subjects with diabetes with wound; This group of subjects will have wound and come for couple of follow up visits for saliva collection, biopsy collection and blood draw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gayle Gordillo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: August 15, 2008
• First Submitted That Met QC Criteria: August 18, 2008
• First Posted (Estimate): August 19, 2008

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Impact of ischemia; Impact of stress and; Identify patterns of gene expression
• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Wounds and Injuries; Neovascularization, Pathologic
• Other Study ID Numbers: 2008H0051