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Mechanisms Regulating Wound Vascularization

NCT ID: NCT00737321

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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

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Wounds and Injuries

Keywords

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Impact of ischemia Impact of stress and Identify patterns of gene expression

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Samples will be collected

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

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Samples will be collected

wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).

Intervention Type PROCEDURE

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gayle Gordillo

OTHER

Sponsor Role lead

Responsible Party

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Gayle Gordillo

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gayle Gordillo, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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OSU East Wound Care Center

Columbus, Ohio, United States

Site Status

OSU Comprehensive Wound Care Center Morehouse

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 10711175 (View on PubMed)

Other Identifiers

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2008H0051

Identifier Type: -

Identifier Source: org_study_id