Abstract
BackgroundVenous leg ulcers constitute a chronic recurring complaint that affects 1.0–1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg. Multilayer compression bandaging is, at present, the only treatment that has been proved to be effective in treating this type of ulcer. There is no consensus, however, about the dressings that may be applied, beneath the compression, to promote the healing of this type of ulcer, as there does not seem to be any added benefit from using special dressings rather than simple, low-adherence ones. As well as analgesia, acupuncture provokes peripheral vasodilation, in skin and muscles – which has been demonstrated both experimentally and in clinical practice – probably due to the axon reflex, among other mechanisms. The aim of the present study is to measure the effectiveness and cost of compression treatment for venous leg ulcers combined with special dressings, in comparison with low-adherence ones and acupuncture.Methods/designCluster-randomized open-labeled trial, at 15 primary healthcare clinics in the Sevilla-Sur Healthcare District, with a control group treated with compression bandaging and low-adherence dressings; the experiment will consist, on the one hand, of the compression treatment applied in combination with special dressings (Treatment 1), and on the other, the compression treatment applied in association with low-adherence dressings, together with acupuncture (Treatment 2).DiscussionThe results will be measured and recorded in terms of the median time elapsed until complete healing of the ulcer, and the rate of complete healing at 3 months after beginning the treatment. An economic analysis will also be made.This study, carried out in the context of real clinical practice, will provide information for decision-taking concerning the effectiveness of special dressings. Moreover, for the first time a high-quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers.Trial registrationCurrent Controlled Trials ISRCTN26438275.
Highlights
Venous leg ulcers constitute a chronic recurring complaint that affects 1.0–1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg
For the first time a high-quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers
Research aims and questions The aim of this study is to determine whether the combination of compression bandaging with simple, lowadherence dressings and acupuncture is more effective than when the same bandaging is employed in combination with special dressings or with simple, low-adherence dressings, but no sensory stimulation, with respect to the complete healing of venous leg ulcers
Summary
Venous leg ulcers constitute a chronic recurring complaint that affects 1.0–1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg. Venous leg ulcers (VLU) constitute a chronic recurring complaint that affects 1.0–1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg [1] They are caused by sustained venous hypertension, which is the result, in almost 50% of cases, from superficial venous insufficiency or from malfunctioning valves in perforating veins, with a normally-functioning deep venous system. Other factors that may result in sustained venous hypertension are those that impede the pumping function of the leg muscles, such as conditions that reduce spontaneous movements (Parkinson's disease, stroke, spinal cord injuries or excessive sedation) This type of chronic venous insufficiency is characterized by oedema, venous dilation, painful legs and stasis dermatitis. The precise procedure by which hypertension leads to ulceration has yet to be clarified, but various mechanisms are known to be capable of intervening in its development and maintenance, such as plasma extravasation, pericapillary deposits of fibrin [3], disorders of the fibrinolytic system [4], the fixing or retention of growth factors by macromolecules in the dermis, or leukocytes in the veins of the legs [5,6,7]
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