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Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

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ClinicalTrials.gov Identifier: NCT01864967
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Institute of Assistance in Plastic Surgery, Sao Paulo

Study Description
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Brief Summary:
Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating local nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow in chronic wounds of the lower limbs.

Condition or disease
Wounds

Detailed Description:
Ten patients with chronic wounds caused by venous insufficiency at both lower limbs were distributed into groups. Group I was composed by wounds in the right lower limb that received carbon dioxide and group II by wounds in the left lower limb that not received carbon dioxide, both related to the same patient. Carbon dioxide infusion was performed with the needle pointed toward the granulation tissue, 5cm distant from each one at intervals of 4 days. Biopsies were collected from the wounds before carbon dioxide infusion and after the 3rd, 5th and 10th application. Statistical analysis of the data was performed using Wilcoxon's test and Friedman's variance analysis and multiple comparisons test.
Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Cross-Sectional
Official Title: Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
Study Start Date : March 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

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Groups and Cohorts
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Group/Cohort
carbon dioxide infusion
Group I: receive carbon dioxide infusion
control
did not receive carbon dioxide


Outcome Measures
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Primary Outcome Measures :
  1. dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts [ Time Frame: 10 sessions (5 weeks) per patient ]

Eligibility Criteria
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Ages Eligible for Study:   49 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
10 patients with chronic wounds on both lower limbs
Criteria

Inclusion Criteria:

  • chronic wounds caused by venous insufficiency

Exclusion Criteria:

  • other diseases of the lower limbs
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864967


Locations
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Brazil
Instute of Assistance in Plastic Surgery of São Paulo
São Paulo, Brazil, 04006-052
Sponsors and Collaborators
Institute of Assistance in Plastic Surgery, Sao Paulo
Investigators
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Study Chair: Antonio CA Abramo, PhD M.D. ACA Institute of Assistance in Plastic Surgery Sao Paulo
More Information
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Responsible Party: Institute of Assistance in Plastic Surgery, Sao Paulo
ClinicalTrials.gov Identifier: NCT01864967    
Other Study ID Numbers: AC-001
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: January 2013
Keywords provided by Institute of Assistance in Plastic Surgery, Sao Paulo:
carbon dioxide infusion
dilatation of peripheral blood vessels
capillaries
 macrophags
fibroblasts
Improvement granulation tissue in chronic wounds
Additional relevant MeSH terms:
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Wounds and Injuries