Compression therapy in venous leg ulcers

INTERVENTION: 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: 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 CONDITION: Physical therapy in wound healing Various types of compression therapy in leg ulcers PRIMARY OUTCOME: Primary outcome was analysis of changes of the total ulcer surface area, volume and linear dimensions inside observed groups ; ; Tests/methods: digital planimetry SECONDARY OUTCOME: The secondary outcome was comparison between all groups the number of completely healed wounds (ulcer healing rates) and percentage change of ulcer surface area ; ; Tests/methods: digital planimetry INCLUSION CRITERIA: Patients with venous leg ulcers were included in the study 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).