Background: Chronic venous ulcer healing is a complex clinical problem that requires intervention from skilled, costly, multidisciplinary wound-care teams. Compression therapy has been shown to help heal venous ulcers and to reduce recurrence. It is not known which interventions help people adhere to compression treatments. This review is an update of a previous Cochrane review.
Objectives: To assess the benefits and harms of interventions designed to help people adhere to venous leg ulcer compression therapy, to improve healing and prevent recurrence after healing.
Search methods: In June 2015, for this first update, we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched trial registries, and reference lists of relevant publications for published and ongoing trials. There were no language or publication date restrictions.
Selection criteria: We included randomised controlled trials (RCTs) of interventions that aim to help people with venous leg ulcers adhere to compression treatments compared with usual care, or no intervention, or another active intervention. Our main outcomes were ulcer healing, ulcer recurrence, quality of life, pain, adherence to compression therapy and number of people with adverse events.
Data collection and analysis: Two review authors independently selected studies for inclusion, extracted data, assessed the risk of bias of each included trial, and assessed overall quality of evidence for the main outcomes in 'Summary of findings' tables.
Main results: One randomised controlled trial was added to this update making a total of three. One ongoing study was also identified. One trial (67 participants) compared a community-based Leg Club® that provided mechanisms for peer-support, assistance with goal setting and social interaction with home-based care. There was no clear difference in healing rates at three months (12/28 people healed in Leg Club group versus 7/28 in home-based care group; risk ratio (RR) 1.71, 95% confidence interval (CI) 0.79 to 3.71); or six months (15/33 healed in Leg Club group versus 10/34 in home-based care group; RR 1.55, 95% CI 0.81 to 2.93); or in quality of life outcomes at six months (MD 0.85 points, 95% CI -0.13 to 1.83; 0 to 10 point scale). The Leg Club may lead to a small reduction in pain at six months, that may not be clinically significant (MD -12.75 points, 95% CI -24.79, -0.71; 0 to 100 point scale, 15 point reduction is usually considered the minimal clinically important difference) (low quality evidence downgraded for risk of selection bias and imprecision). Another trial (184 participants) compared a community-based, nurse-led self-management programme of six months' duration promoting physical activity (walking and leg exercises) and adherence to compression therapy via counselling and behaviour modification (Lively Legs®) with usual care in a wound clinic. At 18 months follow-up, there were no clear differences in healing rates (51/92 healed in Lively Legs group versus 41/92 in usual care group; RR 1.24 (95% CI 0.93 to 1.67)); rates of recurrence of venous leg ulcers (32/69 with recurrence in Lively Legs group versus 38/67 in usual care group; RR 0.82 (95% CI 0.59 to 1.14)); or adherence to compression therapy (42/92 people fully adherent in Lively Legs group versus 41/92 in usual care group; RR 1.02 (95% CI 0.74 to 1.41)). The evidence from this trial was also downgraded to low quality due to risk of selection bias and imprecision. A single study compared patient education delivered via video with education delivered by text (pamphlet). However, no outcomes relevant to this review were reported. We found no studies that investigated other interventions to promote adherence to compression therapy.
Authors' conclusions: It is unclear whether interventions designed to help people adhere to compression therapy improve venous ulcer healing and reduce recurrence. There is a lack of trials of interventions that promote adherence to compression therapy for venous ulcers.