Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

Wounds Clinical Trial

Official title:

Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864967
• Other study ID #: AC-001
• Status: Completed
• Phase: N/A
• First received: November 23, 2008
• Last updated: May 23, 2013
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2013
• Source: Institute of Assistance in Plastic Surgery, Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 49 Years to 59 Years

Eligibility

Inclusion Criteria:

• chronic wounds caused by venous insufficiency

Exclusion Criteria:

• other diseases of the lower limbs

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Wounds

Locations

Country	Name	City	State
Brazil	Instute of Assistance in Plastic Surgery of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Assistance in Plastic Surgery, Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts		10 sessions (5 weeks) per patient	Yes