None listed
Conditions
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.
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
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.
Sponsors
Medical University of Silesia, Katowice, Poland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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
Outcome results
None listed