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Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 23, 2008
First Posted Date May 30, 2013
Last Update Posted Date May 30, 2013
Study Start Date March 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2013)
dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts [ Time Frame: 10 sessions (5 weeks) per patient ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
Official Title Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
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.
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 Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 10 patients with chronic wounds on both lower limbs
Condition Wounds
Intervention Not Provided
Study Groups/Cohorts
  • carbon dioxide infusion
    Group I: receive carbon dioxide infusion
  • control
    did not receive carbon dioxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 23, 2013)
10
Original Actual Enrollment Same as current
Actual Study Completion Date August 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • chronic wounds caused by venous insufficiency

Exclusion Criteria:

  • other diseases of the lower limbs
Sex/Gender
Sexes Eligible for Study: All
Ages 49 Years to 59 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01864967
Other Study ID Numbers AC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Institute of Assistance in Plastic Surgery, Sao Paulo
Study Sponsor Institute of Assistance in Plastic Surgery, Sao Paulo
Collaborators Not Provided
Investigators
Study Chair: Antonio CA Abramo, PhD M.D. ACA Institute of Assistance in Plastic Surgery Sao Paulo
PRS Account Institute of Assistance in Plastic Surgery, Sao Paulo
Verification Date January 2013