Clincosm LogoSign in Get a demo

Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

Sponsor
Institute of Assistance in Plastic Surgery, Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01864967
Collaborator
(none)
10
Enrollment
1
Location
17.1
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Mar 1, 2007
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Aug 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    carbon dioxide infusion

    Group I: receive carbon dioxide infusion
    control

    did not receive carbon dioxide

    Outcome Measures

    Primary Outcome Measures

    1. dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts [10 sessions (5 weeks) per patient]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    49 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • chronic wounds caused by venous insufficiency
    Exclusion Criteria:
    • other diseases of the lower limbs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Study Chair: Antonio CA Abramo, PhD M.D., ACA Institute of Assistance in Plastic Surgery Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Last Update Posted:
    May 30, 2013
    Last Verified:
    Jan 1, 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:
    Wounds and Injuries

    Study Results

    No Results Posted as of May 30, 2013