RecruitingACTRN12624000636550

Assessment of the effectiveness of carbon dioxide "bath" in the treatment of venous leg ulcers.

The effect of carbon dioxide "bath" on wound size and pain intensity in patients with venous leg ulcer.

Sponsor

Medical University of Silesia, Katowice, Poland

Enrollment

60 participants

Start Date

Jan 2, 2024

Study Type

Interventional

Conditions

chronic venous ulcers

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Venous leg ulcers are open wounds on the lower leg caused by poor blood circulation in the veins. They are slow to heal and affect a significant number of older adults. Compression therapy (bandaging) is the gold standard treatment, but this study is investigating whether adding carbon dioxide 'baths' — a type of spa therapy where the leg is immersed in CO₂-enriched water — can speed up healing. CO₂ baths are thought to improve blood circulation in the skin and around wounds. This study, led by the Medical University of Silesia in Poland, will compare healing outcomes between patients who receive compression alone and those who receive compression plus CO₂ bath therapy. You may be eligible if you are aged 18–80 and have a venous leg ulcer that has been present for more than one month. People with diabetes, cancer, heart failure, pulmonary oedema, peripheral nerve injury, rheumatoid arthritis, a pacemaker, ventricular arrhythmia, lymphoedema, or bilateral ulcers are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

Locations(1)

Silesia, Poland

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ACTRN12624000636550