Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001038280
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
4/12/2009
Date last updated
4/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Carbon dioxide infusion: clinical and histological appraisal in chronic wounds
Scientific title
Assessing dilation of peripheral blood vessels from carbon dioxide treatment for patients with chronic wounds.
Secondary ID [1] 262345 0
Nil
Universal Trial Number (UTN)
Trial acronym
CDI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic wounds caused by venous insufficiency 243431 0
Condition category
Condition code
Skin 239706 239706 0 0
Dermatological conditions
Cardiovascular 239707 239707 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The application of medical carbon dioxide gas through the skin 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. The volume of carbon dioxide injected was 1.5mlCO2/kg per puncture per session by wound with a pressure flow of 80mlCO2/min. Carbon dioxide was applied on wounds of Group I with a 30G 1/2 needle attached to a digital, programmable, gas heated carbon dioxide device, Carbtek Advanced by ESTEK Tecnologia em Produtos - DAF Produtos Hospitalares Ltda EPP. Punctures were done 2.5cm distant from each other along the border of the wound with the needle pointed toward the granulation tissue. Carbon dioxide infusions were performed at intervals of 4 days, each one constituting an individual time of observation or session. The wounds on both lower limbs were caused by venous insufficiency, ranging from 10 to 14 months, mean of 11.7 months for Group I and 11.3 months for Group II. Carbon dioxide infusions were performed at intervals of 4 days, each one constituting an individual time of observation or session. It was repeated until a brilliant red color with small bleeding during the dressing exchange might be found on the granulation tissue.
Intervention code [1] 237037 0
Treatment: Devices
Intervention code [2] 237038 0
Treatment: Other
Comparator / control treatment
Group II did not receive carbon dioxide infusion. Wounds of Group II do not received carbon dioxide constituting the control group.
Control group
Active

Outcomes
Primary outcome [1] 240476 0
Patients with chronic wounds caused by venous insufficiency at both lower limbs were distributed into 2 groups. Carbon dioxide infusion was performed with the needle pointed toward the granulation tissue, 2.5cm distant from each one.
Timepoint [1] 240476 0
5 weeks from randomisation: Carbon dioxide infusion was performed at intervals of 4 days. Biopsies were collected from the wounds before carbon dioxide infusion and after the 3rd, 5th and 10th application.
Secondary outcome [1] 257017 0
'Nil'
Timepoint [1] 257017 0
'Nil'

Eligibility
Key inclusion criteria
Patients with chronic wounds.
Minimum age
49 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No smokers

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Carbon dioxide insuflation into the margins of the wound
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Chronic wounds at the lower limbs caused by venous insufficience
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
by comparison:
The wounds on both lower limbs were caused by venous insufficiency, ranging from 10 to 14 months, mean of 11.7 months for Group I and 11.3 months for Group II. Group I was composed by wounds on right lower limb and Group II by wounds on left lower limb, both in the same patient.
Group I: received CO2 - Group II: Not received CO2, been used as control group.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1923 0
Brazil
State/province [1] 1923 0
SP/Sao Paulo

Funding & Sponsors
Funding source category [1] 237412 0
Other
Name [1] 237412 0
Institute of Assistance in Plastic Surgery of Sao Paulo
Country [1] 237412 0
Brazil
Funding source category [2] 267224 0
Other
Name [2] 267224 0
Antonio Carlos Abramo
Country [2] 267224 0
Brazil
Primary sponsor type
Other
Name
Institute of Assistance in Plastic Surgery of Sao Paulo
Address
Rua Afonso de Freitas, 641 - 04006-052 - Sao Paulo, SP
Country
Brazil
Secondary sponsor category [1] 236909 0
Commercial sector/Industry
Name [1] 236909 0
ESTEK Tecnologia em Produtos
DAF Produtos Hospitalares Ltda EPP
ESTEK Tecnologia em Produtos
DAF Produtos Hospitalares Ltda EPP
ESTEK Tecnologia em Produtos
DAF Produtos Hospitalares Ltda EPP
Address [1] 236909 0
Av. Ibiuna, 86 - Vila Aricanduva - Sao Paulo - SP - 03507-010
Country [1] 236909 0
Brazil
Secondary sponsor category [2] 266289 0
None
Name [2] 266289 0
Address [2] 266289 0
Country [2] 266289 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29985 0
Address 29985 0
Country 29985 0
Phone 29985 0
Fax 29985 0
Email 29985 0
Contact person for public queries
Name 13232 0
ANTONIO CARLOS ABRAMO, M.D., Ph. D.,
Address 13232 0
Rua Afonso de Freitas, 641 - 04006-052 - Sao Paulo, SP
Country 13232 0
Brazil
Phone 13232 0
55 11 3052.1864
Fax 13232 0
55 11 3884.3671
Email 13232 0
[email protected]
Contact person for scientific queries
Name 4160 0
ANTONIO CARLOS ABRAMO, M.D., Ph. D.,
Address 4160 0
Rua Afonso de Freitas, 641 - 04006-052 - Sao Paulo, SP
Country 4160 0
Brazil
Phone 4160 0
55 11 3052.1864
Fax 4160 0
55 11 3884.3671
Email 4160 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.