Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
Varicose Ulcer
About this trial
This is an interventional treatment trial for Varicose Ulcer focused on measuring Varicose ulcer, Compressive therapy, Venous ulcer, Chronic venous disease
Eligibility Criteria
Inclusion Criteria:
- Venous ulcers due to chronic venous disease assessed by color duplex scan (CDS) examination in standing position. Reflux will be assessed using CDS over a longitudinal vein through the manual compression of the calf in a distant position from the examined area. Reflux will be considered pathological if: >0.5 seconds (s) in the superficial venous system, or > 1.0 s in the deep system, or > 0.35 s in a perforator vein.
Exclusion Criteria:
- Investigators will exclude patients with ulcers from any other cause, including arterial insufficiency, with ankle-brachial pressure index (ABPI) < 0.8. Also will be excluded patients who use immunosuppressive and chemotherapy drugs, who have allergies to compression materials, and wheelchair users (due to the impossibility of performing the exercises).
Sites / Locations
- Pró-Circulação - Clinic of Angiology and Vascular SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Vein Fitness
Control group
Lymphomiokinetic exercises will be performed during a 1 hour period, with the patients in a supine position, legs elevated and properly positioned on a carpet; the knees will be mildly flexed to a comfortable point. The patients will put feet on the pedals of ankle extension/flexion device. The frequency will be around 15 to 20 cycles/minute, while the amplitude will be individually adjusted according to the range of movement of each patient. During the exercises, study personnel will manually drain the lower members. Compressive therapy will be applied as described in the control group arm. Care of the wound will be delivered as described in the control group arm.
Compressive therapy will be applied to both groups by properly trained personnel. Each layer of the compressive boot will have a 50% overlap, from the base to of the fingers to 3 cm bellow the popliteal fossa. The interface pressure used will be of at least 50mmHg in supine position. Wound care will be delivered to every individual in both groups, 1 or 2 times each week by a nurse certified in wound management, following the principles of maintenance of a moisturized surface between the wound and its cover. The nurse will also carry out mechanical wound debriding and biofilm removal.