Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

NCT ID: NCT01864967

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-08-31

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.

Conditions

Wounds

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

carbon dioxide infusion

Group I: receive carbon dioxide infusion

No interventions assigned to this group

control

did not receive carbon dioxide

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• chronic wounds caused by venous insufficiency

Exclusion Criteria

• other diseases of the lower limbs

• Minimum Eligible Age: 49 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Assistance in Plastic Surgery, Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio CA Abramo, PhD M.D.

Role: STUDY_CHAIR

ACA Institute of Assistance in Plastic Surgery Sao Paulo

Locations

Instute of Assistance in Plastic Surgery of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

AC-001

Identifier Type: -

Identifier Source: org_study_id