Mechanisms Regulating Wound Vascularization

NCT00737321 | Terminated

• 1 other identifier: 2008H0051
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Wounds and Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Interventions

Samples will be collected PROCEDURE

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

2- Diabetics without wound (s)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18-69 years
• ischemic wound group
• non-ischemic wound group
• diabetes with good glycemic control
• lower extremity wound

You may not qualify if:

• 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%

Sponsors & Collaborators

• Gayle Gordillo: lead

Study Sites (2)

OSU East Wound Care Center

Columbus, Ohio, 43205, United States

Location

OSU Comprehensive Wound Care Center Morehouse

Columbus, Ohio, 43221, United States

Location

Related 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. No abstract available.

  PMID: 10711175 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

All participnts with wounds will have 3 mm punch biopsy performed twice or three times in the whole study period.Obtained tissue sample will be processed immidiately and frozen in liquid nitrogen.The tissue sample will transport to research lab for genomic analysis.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Gayle Gordillo, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 19, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

US (2)