The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies.
ABSTRACT: BACKGROUND: OBJECTIVE:To determine the relative effectiveness of evidence-informed practice using two high compression systems: four-layer (4LB) and short-stretch bandaging (SSB) in community care of venous leg ulcers. DESIGN AND SETTING:Pragmatic, multi-centre, parallel-group, open-label, randomized controlled trial conducted in 10 centres. Cognitively intact adults (?18 years) referred for community care (home or clinic) with a venous ulceration measuring ?0.7cm and present for ?1 week, with an ankle brachial pressure index (ABPI) ?0.8, without medication-controlled Diabetes Mellitus or a previous failure to improve with either system, were eligible to participate. METHODS:Consenting individuals were randomly allocated (computer-generated blocked randomization schedule) to receive either 4LB or SSB following an evidence-informed protocol. Primary endpoint: time-to- healing of the reference ulcer. SECONDARY OUTCOMES:recurrence rates, health-related quality of life (HRQL), pain, and expenditures. RESULTS:424 individuals were randomized (4LB n = 215; SSB n = 209) and followed until their reference ulcer was healed (or maximum 30 months). An intent-to-treat analysis was conducted on all participants. Median time to ulcer healing in the 4LB group was 62 days [95% confidence interval (CI) 51 to 73], compared with 77 days (95% CI 63 to 91) in the SSB group. The unadjusted Kaplan-Meier curves revealed the difference in the distribution of cumulative healing times was not significantly different between group (log rank ?2 = 0.001, P = 0.98) nor ulcers recurrence (4LB, 10.1%; SSB, 13.3%; p = 0.345). Multivariable Cox Proportional Hazard Modeling also showed no significant between-bandage differences in healing time after controlling for significant covariates (p = 0.77). At 3-months post-baseline there were no differences in pain (no pain: 4LB, 22.7%; SSB, 26.7%; p = 0.335), or HRQL (SF-12 Mental Component Score: 4LB, 55.1; SSB, 55.8; p = 0.615; SF-12 Physical Component Score: 4LB, 39.0; SSB, 39.6; p = 0.675). The most common adverse events experienced by both groups included infection, skin breakdown and ulcer deterioration. CONCLUSIONS:The Canadian Bandaging Trial revealed that in the practice context of trained RNs using an evidence-informed protocol, the choice of bandage system (4LB and SSB) does not materially affect healing times, recurrence rates, HRQL, or pain. From a community practice perspective, this is positive news for patient-centred care allowing individual/family and practitioner choice in selecting compression technologies based on circumstances and context. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00202267.
Project description:Venous leg ulcers, affecting approximately 1% of the population, are costly to manage due to poor healing and high recurrence rates. We evaluated an evidence-informed leg ulcer care protocol with two frequently used high compression systems: 'four-layer bandage' (4LB) and 'short-stretch bandage' (SSB).We conducted a cost-effectiveness analysis using individual patient data from the Canadian Bandaging Trial, a publicly funded, pragmatic, randomized trial evaluating high compression therapy with 4LB (n = 215) and SSB (n = 209) for community care of venous leg ulcers. We estimated costs (in 2009-2010 Canadian dollars) from the societal perspective and used a time horizon corresponding to each trial participant's first year.Relative to SSB, 4LB was associated with an average 15 ulcer-free days gained, although the 95% confidence interval [-32, 21 days] crossed zero, indicating no treatment difference; an average health benefit of 0.009 QALYs gained [-0.019, 0.037] and overall, an average cost increase of $420 [$235, $739] (due to twice as many 4LB bandages used); or equivalently, a cost of $46,667 per QALY gained. If decision makers are willing to pay from $50,000 to $100,000 per QALY, the probability of 4LB being more cost effective increased from 51% to 63%.Our findings differ from the emerging clinical and economic evidence that supports high compression therapy with 4LB, and therefore suggest another perspective on high compression practice, namely when delivered by trained registered nurses using an evidence-informed protocol, both 4LB and SSB systems offer comparable effectiveness and value for money.
Project description:BACKGROUND:Chronic wounds are managed almost entirely by community nurses. Almost all individuals with leg ulcers report acute pain usually related to dressing change. Little is known about pain after healing. The purpose of this study was to explore the course of pain from baseline to time of healing of leg ulcers (venous or mixed etiology). In order to understand this phenomenon and develop implications for nursing practice, objectives included: 1) Measure incidence and prevalence of pain at baseline and healing; 2) Describe characteristics associated with leg ulcer pain at baseline; 3) Identify predictors of leg ulcer pain at healing. METHODS:Data were from one randomized controlled trial (2004-2008) of 424 individuals with leg ulcers in the community receiving evidence-informed nursing management. The primary outcome was pain at the time of healing. Predictive factors included demographic, circumstance of living, clinical and ulcer characteristics. Multivariable logistic regression identified the subset of predictors of pain at healing. Odds ratios (OR) and 95% confidence intervals (CI) are reported. RESULTS:Eighty-two percent of participants reported pain at baseline and 32% at healing. Five percent with no pain at baseline reported pain at healing. Thirty-seven percent reported moderate to severe pain at baseline and 11% at healing. Twenty percent of all those who healed reported pain interfered with work moderately to extremely at time of healing. Being female (OR=1.64, 95% CI 1.00, 2.68, p=0.05), use of short-stretch vs. four-layer bandages (OR=1.73, 95% CI 1.06, 2.82, p=0.03), lower SF-12 PCS (OR=0.97, 95% CI 0.94, 0.99, p=0.02) and MCS (OR=0.98, 95% CI 0.95-1.00, p=0.04) scores, use of non-steroidal anti-inflammatory drugs (OR=2.28, 95% CI 1.06, 4.88, p=0.03), and tender pain (OR=2.17, 95% CI 1.29, 3.66, p=<0.01) were associated with pain at time of healing. CONCLUSIONS:Pain is an issue on admission for chronic wounds and at healing, yet 58% with moderate to severe pain on admission were not taking pain medication(s). Future studies should examine the role of pain at healing and at subsequent ulcer recurrence. Mobility and other factors that may contribute to pain at time of healing should also be assessed. Community nurses are encouraged to consider pain when planning care on admission and also after wound healing, when most patients are discharged from care. TRIAL REGISTRATION:ClinicalTrials.gov, NCT00202267.
Project description:International studies report that nurse clinics improve healing rates for the leg ulcer population. However, these studies did not necessarily deliver similar standards of care based on evidence in the treatment venues (home and clinic). A rigorous evaluation of home versus clinic care is required to determine healing rates with equivalent care and establish the acceptability of clinic-delivered care.Health Services RCT was conducted where mobile individuals were allocated to either home or nurse clinic for leg ulcer management. In both arms, care was delivered by specially trained nurses, following an evidence protocol.3-month healing rates.durability of healing (recurrence), time free of ulcers, HRQL, satisfaction, resource use. Data were collected at base-line, every 3 months until healing occurred, with 1 year follow-up. Analysis was by intention to treat.126 participants, 65 randomized to receive care in their homes, 61 to nurse-run clinics. No differences found between groups at baseline on socio-demographic, HRQL or clinical characteristics. mean age 69 years, 68% females, 84% English-speaking, half with previous episode of ulceration, 60% ulcers at inclusion < 5 cm2 for < 6 months. No differences in 3-month healing rates: clinic 58.3% compared to home care at 56.7% (p = 0.5) or in secondary outcomes.Our findings indicate that organization of care not the setting where care is delivered influences healing rates. Key factors are a system that supports delivery of evidence-based recommendations with care being provided by a trained nursing team resulting in equivalent healing rates, HRQL whether care is delivered in the home or in a community nurse-led clinic.ClinicalTrials.gov Protocol Registration System: NCT00656383.
Project description:The gap junction protein, connexin43 (Cx43), has critical roles in the inflammatory, edematous, and fibrotic processes following dermal injury and during wound healing, and is abnormally upregulated at the epidermal wound margins of venous leg ulcers (VLUs). Targeting Cx43 with ACT1, a peptide mimetic of the carboxyl-terminus of Cx43, accelerates fibroblast migration and proliferation, and wound reepithelialization. In a prospective, multicenter clinical trial conducted in India, adults with chronic VLUs were randomized to treatment with an ACT1 gel formulation plus conventional standard-of-care (SOC) protocols, involving maintaining wound moisture and four-layer compression bandage therapy, or SOC protocols alone. The primary end point was mean percent ulcer reepithelialization from baseline to 12 weeks. A significantly greater reduction in mean percent ulcer area from baseline to 12 weeks was associated with the incorporation of ACT1 therapy (79% (SD 50.4)) as compared with compression bandage therapy alone (36% (SD 179.8); P=0.02). Evaluation of secondary efficacy end points indicated a reduced median time to 50 and 100% ulcer reepithelialization for ACT1-treated ulcers. Incorporation of ACT1 in SOC protocols may represent a well-tolerated, highly effective therapeutic strategy that expedites chronic venous ulcer healing by treating the underlying ulcer pathophysiology through Cx43-mediated pathways.
Project description:Venous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing.This randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks.The ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018.Australian New Zealand Clinical Trials Registry, ACTRN12614000293662.
Project description:OBJECTIVE:To determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers. DESIGN:Randomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials. SETTING:Leg ulcer clinics of a teaching and a district general hospital in southern Scotland. PARTICIPANTS:200 patients with confirmed venous ulcers and in whom other major causal factors were excluded. INTERVENTIONS:Pentoxifylline 400 mg three times daily or placebo. MAIN OUTCOME MEASURE:Complete healing (full epithelialisation) of all ulcers on the trial leg. RESULTS:Complete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo. CONCLUSIONS:The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance.
Project description:Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence. Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts. While casting in plaster is usually effective in achieving primary closure of foot ulcers, recurrence rates are high. Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results. The surgery alleviates the pressure under the bony prominence, thus enabling prompt ulcer healing, negating the patient's dependence on expensive shoes and orthotics, with a lower chance of recurrence. The purpose of this protocol is to compare offloading surgery (percutaneous flexor tenotomy, mini-invasive floating metatarsal osteotomy or Keller arthroplasty) to non-surgical treatment for patients with diabetic foot ulcers in a semi-crossover designed RCT.One hundred patients with diabetic neuropathy related foot ulcers (tip of toe ulcers, ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint) will be randomized (2:3) to a surgical offloading procedure or best available non-surgical treatment. Group 1 (surgery) will have surgery within 1 week. Group 2 (controls) will be prescribed an offloading cast applied for up to 12 weeks (based on clinical considerations). Following successful offloading treatment (ulcer closure with complete epithelization) patients will be prescribed orthopaedic shoes and custom made orthotics. If offloading by cast for at least 6 weeks fails, or the ulcer recurs, patients will be offered surgical offloading. Follow-up will take place till 2 years following randomization. Outcome criteria will be time to healing of the primary ulcer (complete epithelization), time to healing of surgical wound, recurrence of ulcer, time to recurrence and complications.The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions than the non-surgical options available at present. To promote surgery, RCT level evidence of efficacy is necessary.Israel MOH_2017-08-10_000719. NIH: NCT03414216.
Project description:BACKGROUND:Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs - it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established. METHODS/DESIGN:AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events. DISCUSSION:The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU. TRIAL REGISTRATION:The study is registered on a public database with clinicaltrials.gov ( NCT02333123 ; registered on 5 November 2014).
Project description:We aimed to assess the ulcer healing time and recurrence rates after treatment with compression therapy (CT) with or without high ligation-endovenous laser ablation-foam sclerotherapy (HL-EVLA-FS) in people with active venous leg ulcers (VLUs). A retrospective cohort study was conducted with 350 patients with active VLUs treated by compression with or without HL-EVLA-FS in our hospital from 2013 to 2017. The primary outcome was the ulcer healing time; secondary outcomes were the 12-month recurrence rates, the relationship between recurrence and venous reflux, and the complications of the two treatments. In total, 193 patients (200 limbs) underwent compression plus HL-EVLA-FS, and 157 patients (177 limbs) underwent CT alone. The ulcer healing time was shorter in the compression plus HL-EVLA-FS group than in the CT alone group (Hazard Ratio [HR] for ulcer healing, 1.845 [95% CI, 1.474-2.309], P = 0.0001). The 12-month ulcer recurrence rates were significantly reduced in the compression plus HL-EVLA-FS group (HR for ulcer recurrence, 0.418 [95% CI, 0.258-0.677], P = 0.0001). Calf perforator vein reflux (CPVR) and isolated superficial venous reflux (ISVR) were risk factors for ulcer recurrence. The combined operation with CT resulted in faster healing of VLUs, a lower ulcer recurrence rate and lower VCSS values after intervention than CT alone.
Project description:Aim:To describe differences in healing time of diabetic foot ulcers for patients treated at the Copenhagen Wound Healing Center, Bispebjerg Hospital, between the years 1999/2000 and 2011/2012. The Center is highly specialized and receives diabetes patients with hard-to-heal foot ulcers. A further aim is to attempt to find predictors of healing time of diabetic foot ulcers. Methods:A retrospective descriptive study of records from patients with diabetic foot ulcer treated at the Copenhagen Wound Healing Center in 1999, 2000, 2011, or 2012. Follow-up data was collected until the 3rd of August 2018. Results:Median time (range) to healing was 6 (61.3) months in 1999/2000 and 6.6 (67.8) in 2011/2012 (p = 0.2). About 33% of ulcers were healed, 17% were minor or major amputated, and 1.5% were dead within one year in 1999/2000, whereas 30% of ulcers were healed (p = 0.6), 14% were amputated (p = 0.2), and 12.8% were dead within one year in 2011/2012 (p < 0.001). The single factor found significantly associated with longer ulcer duration was infection. Related to shorter ulcer duration were toe localization of the ulcer and good glycemic control. Conclusion:The median time to healing of a diabetic foot ulcer was long, around 6 months and with a high recurrence rate in 1999/2000 as well as in 2011/2012. Some factors were found to be significantly related to healing time, and intervention addressing these may improve the time to heal, although such interpretations must be taken with precaution from the present study and should be proven in randomized prospective intervention trials.