WoundsNCT01864967
Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
An observational study of Wounds, run by Institute of Assistance in Plastic Surgery, Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 49 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 10 patients with chronic wounds on both lower limbs
Who may be able to join
- chronic wounds caused by venous insufficiency
Who cannot join
- other diseases of the lower limbs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instute of Assistance in Plastic Surgery of São Paulo
São Paulo, São Paulo, 04006-052
About this study
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.
Read the 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
- Keywords
- carbon dioxide infusion, dilatation of peripheral blood vessels, capillaries, macrophags, fibroblasts, Improvement granulation tissue in chronic wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| carbon dioxide infusion | Group I: receive carbon dioxide infusion | |
| control | did not receive carbon dioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts
Measured: 10 sessions (5 weeks) per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Assistance in Plastic Surgery, Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio CA Abramo, PhD M.D., Study chair, ACA Institute of Assistance in Plastic Surgery Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864967
- Sponsor's protocol ID
- AC-001
- Status last verified
- Jan 2013
- First submitted
- 23 Nov 2008
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
- ClinicalTrials.gov ID
- NCT01864967
- Acronym / sponsor ID
- AC-001
- Conditions
- Wounds
- Keywords
- carbon dioxide infusion, dilatation of peripheral blood vessels, capillaries, macrophags, fibroblasts, Improvement granulation tissue in chronic wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institute of Assistance in Plastic Surgery, Sao PauloUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carbon dioxide infusion | – | –Group I: receive carbon dioxide infusion |
| control | – | –did not receive carbon dioxide |
Who may qualify
- Ages
- 49 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 10 patients with chronic wounds on both lower limbs
Key inclusion criteria (1 listed)
- chronic wounds caused by venous insufficiency
Key exclusion criteria (1 listed)
- other diseases of the lower limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts
Time frame: 10 sessions (5 weeks) per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
Related trials for Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio CA Abramo, PhD M.D. study chair
ACA Institute of Assistance in Plastic Surgery Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by Institute of Assistance in Plastic Surgery, Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts (time frame: 10 sessions (5 weeks) per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.