Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000636550
Ethics application status
Approved
Date submitted
19/03/2024
Date registered
16/05/2024
Date last updated
16/05/2024
Date data sharing statement initially provided
16/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the effectiveness of carbon dioxide "bath" in the treatment of venous leg ulcers.
Scientific title
The effect of carbon dioxide "bath" on wound size and pain intensity in patients with venous leg ulcer.
Secondary ID [1] 311637 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic venous ulcers 333079 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329774 329774 0 0
Other physical medicine / rehabilitation
Skin 329775 329775 0 0
Other skin conditions
Cardiovascular 330332 330332 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research project plans to create two homogeneous comparison groups (60 patients). The therapy will take place at the Dermatology Clinic of the Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice.
Patients will be randomly assigned to specific groups
Group 1 (using carbon dioxide "bath") with venous ulcer: treatment (n=30) will be performed in the form of 10 treatments, 20 minutes each treatment, using a CO2 application device. The treatments are performed twice a week for 5 weeks. The chamber saturation with dioxide should be in the range of 95-100%, and the treatment temperature should be in the range of 30-40°C (+/- 1°). The patient will be placed in a special bed, which will be covered with a cover under which CO2 gas will be released. In addition, patients will receive standard wound care, i.e. changing dressings and ensuring appropriate physiological conditions under the dressing. The results will be blinded and saved in a computer file. Each group treatment will be conducted by one doctor, checking attendance.
Intervention code [1] 328100 0
Rehabilitation
Intervention code [2] 328101 0
Treatment: Devices
Comparator / control treatment
Group 2 (without the use of carbon dioxide "bath" with venous ulcer: treatment (n=30) will be in the form of standard wound care, i.e. dressings, taking care of the appropriate wound environment in accordance with the guidelines of the Polish Wound Treatment Society. The results will be blinded and saved in a computer file. Each group treatment will be conducted by one an physician, checking attendance. The treatments are performed twice a week for 5 weeks.
Control group
Active

Outcomes
Primary outcome [1] 337719 0
Any change in the surface area and circumference of the wound will be analyzed.
Timepoint [1] 337719 0
Wound size will be measured at baseline before the first treatment session and immediately following completion of the last treatment session
Secondary outcome [1] 432963 0
The secondary result is the factors of aggregation and elongation of blood cells of the patients' blood. 5 ml of venous blood will be analyzed.
Timepoint [1] 432963 0
The factors of aggregation and elongation will be measured at baseline before the first treatment session and immediately following completion of the last treatment session.
Secondary outcome [2] 434515 0
Any change in pain intensity of wound will be analyzed.
Timepoint [2] 434515 0
The pain intensity will be measured at baseline before the first treatment session and immediately following completion of the last treatment session.
Secondary outcome [3] 434517 0
The result is the viscosity of blood and plasma will be examined. 5 ml of venous blood will be analyzed.
Timepoint [3] 434517 0
The viscosity of blood and plasma will be determined using a Brookfield rotational viscometer at a stabilized temperature of 37oC.

Eligibility
Key inclusion criteria
Patients with venous leg ulcers were included in the study.
Obtain voluntary and informed consent of the patient to participate in the study.
Chronic wound duration more than 1 month.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were:
an ankle brachial pressure index (ABPI) lower than 1.0,
diabetes,
cancer,
peripheral nerve injury,
rheumatoid arthritis,
ventricular arrhythmia,
cardiac pacemaker,
ulcer surgery,
skin infection,
pregnancy
after steroid therapy,
bilateral ulcers.
lymphedema,
pulmonary edema
congestive heart failure

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)
Computer-generated random numbers using the website www.random.org were assigned to patients, and group assignment was independent of time and treatment providers. The doctor assigning patients in real time generated subsequent numbers for patients and assigned them to study group (Group 1) and control group (Group 2). The doctor qualifying for the study did not participate in the treatment of patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers generated using the website www.random.org.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The obtained results will be subjected to statistical analysis made with Microsoft Excel and the STATISTICA software (TIBCO Software Inc. (2017). Statistica (data analysis software system), version 13. http://statistica.io.).
The statistical analysis of the results will be performed using either parametric or nonparametric tests, depending on the distribution of variable (Shapiro-Wilk test).
The level of statistical significance will be p < 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/01/2024
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26207 0
Poland
State/province [1] 26207 0
Silesia

Funding & Sponsors
Funding source category [1] 315960 0
University
Name [1] 315960 0
Medical University of Silesia, Katowice, Poland
Country [1] 315960 0
Poland
Primary sponsor type
University
Name
Medical University of Silesia, Katowice, Poland
Address
Country
Poland
Secondary sponsor category [1] 318100 0
University
Name [1] 318100 0
Medical University of Silesia, Katowice, Poland
Address [1] 318100 0
Country [1] 318100 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314787 0
Bioethics Committee of the Medical University of Silesia in Katowice
Ethics committee address [1] 314787 0
Medical University of Silesia, Poniatowskiego 15, 40-055 Katowice, Poland
Ethics committee country [1] 314787 0
Poland
Date submitted for ethics approval [1] 314787 0
26/04/2023
Approval date [1] 314787 0
26/06/2023
Ethics approval number [1] 314787 0

Summary
Brief summary
About 3-5% of the population over the age of 65 will develop leg ulcers during their lifetime. Venous leg ulcers constitute a serious clinical problem and an economic burden for the patient and the medical system. The gold standard for supporting ulcer healing is compression therapy. However, supporting it with physical therapy improves its effectiveness. Spa studies examined the effectiveness of carbonic acid baths in the treatment of leg ulcers. Unfortunately, not all treatment mechanisms have been reported and differences in individual studies are not always clearly explained.
Trial website
Trial related presentations / publications
Public notes
Only patients who gave their written consent to participate in the study were included in the study.

Contacts
Principal investigator
Name 132730 0
Prof Patrycja Dolibog
Address 132730 0
Department of Medical Biophysics Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland Medyków 18 Street 40-752 Katowice
Country 132730 0
Poland
Phone 132730 0
+48322088424
Fax 132730 0
Email 132730 0
pdolibog@sum.edu.pl
Contact person for public queries
Name 132731 0
Pawel Dolibog
Address 132731 0
Department of Medical Biophysics Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland Jordana 19 Street Zabrze
Country 132731 0
Poland
Phone 132731 0
+48322088424
Fax 132731 0
Email 132731 0
pawel.dolibog@sum.edu.pl
Contact person for scientific queries
Name 132732 0
Pawel Dolibog
Address 132732 0
Department of Medical Biophysics Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland Jordana 19 Street Zabrze
Country 132732 0
Poland
Phone 132732 0
+48322088424
Fax 132732 0
Email 132732 0
pawel.dolibog@sum.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.