None listed
Conditions
Brief summary
Venous leg ulcers pose a serious clinical dilemma and an economic burden on health services. About 1%–2% of the whole population and 3%–5% of the population over 65 years of age will suffer from a leg ulcer during their lifetime. However, in a typical Western population where the average age is steadily increasing, the burden placed upon the health economy by venous ulceration looks set to increase proportionally. Cost effective treatment of venous disorders is therefore vital. Venous ulcers alone have been estimated to cost the National Health Service 400 million British Pounds a year in the United Kingdom. Studies in Germany calculated the mean total cost of a leg ulcer per patient per year to be 9569 Euros (8658 Euros - 92% direct costs). According to reports the financial burden of venous ulcers is estimated to be 2 billion American Dollars per year in the United States. Clinical studies have examined the efficient effects of compression therapy on leg ulcers. But in the literature, there are many methods of applying external graduated compression, such as elasticised bandages, Unna’s boots, multilayer elastic compression bandages, short stretch bandages and elastomeric hosiery. The differences in effectiveness of various types of compression are not clear. The authors are still not sure as to which compression techniques, and pressure values are clinically the best, easy to use and not expensive.
Interventions
The aim of this study was to compare five types of compression therapy in venous leg ulcers (intermittent pneumatic vs. stockings vs. multi layer vs. two layer short stretch bandages vs. Unna boots). Primary study endpoints were analysis of changes of the total ulcer surface area, volume and linear dimensions inside observed groups. The secondary end points were comparisons between all groups the number of completely healed wounds (ulcer healing rates) and percentage change of ulcer surface area. Intervention: In total, 147 patients with unilateral venous leg ulcers were included to this study. Participants were randomly allocated to the groups: A, B, C, D and E. All participating facilities provided patients a standard regimen of drug therapy (standard regimen was carried out for 2 months to begin our experiment – application one of five compression procedures in following group), including micronized purified flavonoid fraction 450 mg diosmin, 50 mg hesperidin, 2 tablets of 500 mg once daily. Patients in group A received 12 - chamber intermittent pneumatic compression therapy. The Flowtron Hydroven 12 System device was applied to compress the cuff covers the foot, lower leg, knee and thigh. Cuff length was 109 cm (a foot for 33 cm). Cuff expanded from foot (circumference 38 cm) to thigh (circumference 71 cm). All patients were subjected to a pressure of 60 mmHg at the ankle. In the upper chamber pressure was exerted smaller and decreases with the height (40 mmHg in the chamber at the level of the groin. Ventricular filling time was 60 s, and a discharge time of 30 s. A single setting lasted 60 min during treatment, patients were lying. Finally, participants received 40 sessions, 5 times weekly (from Monday to Friday), once a day. Patients in group B were treated with special ulcer stocking system Ulcer X providing pressure 30 – 40 mmHg at the ankle. The system were put on the leg at the outpatient clinic every morning and worn whole day (about 10–12 hours); and put off on night. Patients in group C were treated with multi layer short-stretch bandaging. The pressure values were also standardized in use of Kikuhime manometer (45–50 mmHg for superficial reflux and 50–55 mmHg for superficial with deep venous reflux). Bandages were applied in four layers with spinal turns on foot and turns in eight on calf. The bandages were worn day (10 – 12 hours) and put off on night. Patients in group D were treated with two layer short-stretch bandaging. The pressure values were also standardized in use of Kikuhime manometer (20–25 mmHg for superficial reflux and 25–30 mmHg for superficial with deep venous reflux). Treatment was with the same methodology as in group C. Patients from group E underwent the compression treatment by means of Unna's boot. After rinsing the wound with physiological sodium chloride solution, Unna's rigid paste bandage was tied around the limbs from below the toes up to the knee. This dressing was changed every 7 days. In all groups therapy lasted two months. The compressions were applied by a clinic physiotherapist, who was a professional practitioner (with 15 years of experience). The therapist completed a course on management of leg ulcers and additional training before experiment (20 days to practice applying bandaging with Kikuhime manometer). The measurements: The therapy progress was assessed using analysis of healing rates and digital planimetry - total ulcer surface area (cm2), length and width (cm), volume (cm3) – in use of digitizer
Sponsors
Study design
Eligibility
Inclusion criteria
Patients with venous leg ulcers were included in the study
Exclusion criteria
The exclusion criteria were: (1) an ankle brachial pressure index (ABPI) lower than 1.0, (2) diabetes, (3) cancer, (4) peripheral nerve injury, (5) rheumatoid arthritis, (6) ventricular arrhythmia, (7) cardiac pacemaker, (8) ulcer surgery, (9) skin infection, (10) pregnancy and (11) after steroid therapy, (12) bilateral ulcers. The (13) lymphedema, (14) pulmonary edema and (15) congestive heart failure, (16) chronic renal failure