Project description:To determine the effects of exercise on VLU healing and exercise adherence, and to provide evidence for clinical practice and scientific investigation. PubMed, Embase and Scopus were searched from inception to 31st March, 2022. Pooled relative risks (RRs), standardised mean differences (SMDs), adherence rate with respective 95% confidence intervals (CIs) were calculated. Quality assessment of included studies were performed using the Cochrane Collaboration risk of bias evaluation. Heterogeneity between enrolled studies was evaluated. We identified eight randomised control studies (RCTs) that met the inclusion criteria. The pooled RR for healing rate was 1.38 (95% CI: 1.14 to 1.66; P = 0.0008) with no significant heterogeneity between component studies (I2 = 0%, P = 0.96). SMD for differences of total range of ankle joint motion (ROAM) at the end and at the initiation of follow-up in the intervention and control groups was 0.87 (95% CI: 0.22, 1.52; P = 0.0091), no significant heterogeneity was detected (I2 = 59%, P = 0.0622). Pooled adherence rate was 64% (95% CI: 53%, 75%) with no significant heterogeneity. Exercise manifested positive effects on VLU healing, range of ankle mobility compared with the control group. Patients' adherence to the exercise regimens was favourable.
Project description:ImportanceExercise is recommended as an adjuvant treatment for venous leg ulceration (VLU) to improve calf muscle pump function. However, the association of exercise with VLU healing has not been properly aggregated, and the effectiveness of different exercise interventions has not been characterized.ObjectiveTo summarize the association of different exercise interventions with VLU healing when used as an adjuvant to any form of compression.Data sourcesThe Cochrane Controlled Trials Register, MEDLINE, Embase, CINAHL, PsycInfo, and SCOPUS databases were searched through October 9, 2017.Study selectionRandomized clinical trials (RCTs) of any exercise compared with no exercise in participants with VLU were included, where compression was used as standard therapy and a healing outcome was reported. Independent title screening and full text review by 2 authors (A.J., J.S.) with appeal to a third author (J.P.) if disagreement was unresolved. Of the 519 articles screened, a total of 6 (1.2%) studies met the inclusion criteria for systematic review, including 5 for meta-analysis.Data extraction and synthesisIndependent quality assessment for Cochrane risk of bias and data extraction by 2 authors with appeal to third author if disagreement unresolved (PRISMA). Data pooled using fixed effects model.Main outcomes and measuresThe a priori primary outcome was any healing outcome (proportion healed, time to healing, or change in ulcer area). Secondary outcomes (adverse events, costs, and health-related quality of life) were only collected if a primary outcome was reported.ResultsSix RCTs were identified and 5 (190 participants) met inclusion criteria for meta-analysis. The exercise interventions were progressive resistance exercise alone (2 RCTs, 53 participants) or combined with prescribed physical activity (2 RCTs, 102 participants), walking only (1 RCT, 35 participants), or ankle exercises (1 RCT, 40 participants). Overall, exercise was associated with increased VLU healing at 12 weeks although the effect was imprecise (additional 14 cases healed per 100 patients; 95% CI, 1-27 cases per 100; P = .04). The combination of progressive resistance exercise plus prescribed physical activity appeared to be most effective, again with imprecision (additional 27 cases healed per 100 patients; 95% CI, 9-45 cases per 100; P = .004).Conclusions and relevanceThe evidence base may now be sufficiently suggestive for clinicians to consider recommending simple progressive resistance and aerobic activity to suitable patients with VLU while further research is produced.
Project description:ObjectiveTo review the evidence of effectiveness of dressings applied to venous leg ulcers.DesignSystematic review and meta-analysis.Data sourcesHand searches of journals and searches of electronic databases, conference proceedings, and bibliographies up to April 2006; contacts with dressing manufacturers for unpublished studies.Studies reviewedAll randomised controlled trials that evaluated dressings applied to venous leg ulcers were eligible for inclusion. Data from eligible studies were extracted and summarised independently by two reviewers using a data extraction sheet. Methodological quality was assessed independently by two reviewers.ResultsThe search strategy identified 254 studies; 42 of these fulfilled the inclusion criteria. Hydrocolloids were no more effective than simple low adherent dressings used beneath compression (eight trials; relative risk for healing with hydrocolloid 1.02, 95% confidence interval 0.83 to 1.28). For other comparisons, insufficient evidence was available to allow firm conclusions to be drawn. None of the dressing comparisons showed evidence that a particular class of dressing healed more ulcers. Some differences existed between dressings in terms of subjective outcome measures and ulcer healing rates. The results were not affected by the size or quality of trials or the unit of randomisation. Insufficient data were available to allow conclusions to be drawn about the relative cost effectiveness of different dressings.ConclusionsThe type of dressing applied beneath compression was not shown to affect ulcer healing. The results of the meta-analysis showed that applying hydrocolloid dressings beneath compression produced no benefit in terms of ulcer healing compared with applying simple low adherent dressings. No conclusive recommendations can be made as to which type of dressing is most cost effective. Decisions on which dressing to apply should be based on the local costs of dressings and the preferences of the practitioner or patient.
Project description:ObjectiveThe purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs).MethodsLiterature searches were conducted in Embase, Medline, Cochrane, and CINAHL databases from inception to December 22, 2021. Eligible studies reported prognostic models aimed at developing, validating, and adjusting multivariable prognostic models that include multiple prognostic factors combined, and that predicted clinical outcomes. Methodological quality was assessed using the CHARMS checklist and PROBAST short form questionnaire.ResultsThirteen studies were identified, of which three were validation studies of previously published models, four reported derivation and validation of models, and the remainder reported derivation models only. There was substantial heterogeneity in the model characteristics, including 11 studies focused on wound healing outcomes reporting 91 different predictors. Three studies shared similar predicted outcomes, follow-up timepoint and used a Cox proportional hazards model. However, these models reported different predictor selection methods and different predictors and it was therefore not feasible to summarize performance, such as discriminative ability.ConclusionsThere are no standout risk prediction models in the literature with promising clinical application for patients with VLUs. Future research should focus on developing and validating high-performing models in wider VLU populations.
Project description:IntroductionChronic venous leg ulcer (VLU) healing is a complex clinical problem. It requires intervention from skilled, costly, multidisciplinary wound-care teams, working with patients to manage their care. Compression therapy has been shown to help heal venous ulcers and to reduce recurrence, with some evidence suggesting the value of exercise as well. These activities require health education and health literacy (HL) as patients must process, understand and consistently apply health information for successful self-management. Research suggests that those most vulnerable to VLUs also tend to have limited HL, but there have been no reviews examining the state of HL in patients with previous or active VLUs. This scoping review aims to examine the level of HL in VLU patients and how HL may link to self-management behaviours (particularly exercise and compression adherence), and their VLU healing generally.Methods and analysisWe will use Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review guidelines and the Levac methodology framework to explore eligible papers that examine the effect of HL on their exercise and compression adherence. Electronic databases will be searched (MEDLINE, EMBASE, the Cochrane Library, PsycInfo and Health, OpenGray), examining for all papers on these subjects published between 2000 and 2020. All studies describing compression and or exercise during VLU management will be included. Study characteristics will be recorded; qualitative data will be extracted and evaluated. Quantitative data will be extracted and summarised.Ethics and disseminationWe will disseminate results through peer-reviewed publications. We will use data (ie, journal articles) from publicly available platforms; so, this study does not require ethical review. The consultation step will be carried out with patients, carers and health professionals as part of an established wound consumer group.
Project description:BackgroundVenous leg ulcers (VLUs) are typically painful and heal slowly. Compression therapy offers high healing rates; however, improvements are not usually sustained. Exercise is a low-cost, low-risk and effective strategy for improving physical and mental health. Little is known about the feasibility and efficacy of supervised exercise training used in combination with compression therapy patients with VLUs.ObjectivesTo assess the feasibility of a 12-week supervised exercise programme as an adjunct therapy to compression in patients with VLUs.MethodsThis was a two-centre, two-arm, parallel-group, randomized feasibility trial. Thirty-nine patients with venous ulcers were recruited and randomized 1 : 1 either to exercise (three sessions weekly) plus compression therapy or compression only. Progress/success criteria included exercise attendance rate, loss to follow-up and patient preference. Baseline assessments were repeated at 12 weeks, 6 months and 1 year, with healing rate and time, ulcer recurrence and infection incidents documented. Intervention and healthcare utilization costs were calculated. Qualitative data were collected to assess participants' experiences.ResultsSeventy-two per cent of the exercise group participants attended all scheduled exercise sessions. No serious adverse events and only two exercise-related adverse events (both increased ulcer discharge) were reported. Loss to follow-up was 5%. At 12 months, median ulcer healing time was lower in the exercise group (13 vs. 34·7 weeks). Mean National Health Service costs were £813·27 for the exercise and £2298·57 for the control group.ConclusionsThe feasibility and acceptability of both the supervised exercise programme in conjunction with compression therapy and the study procedures is supported.
Project description:BackgroundRecent advancements in near-infrared fluorescence lymphatic imaging (NIRFLI) technology provide opportunities for non-invasive, real-time assessment of lymphatic contribution in the etiology and treatment of ulcers. The objective of this study was to assess lymphatics in subjects with venous leg ulcers using NIRFLI and to assess lymphatic impact of a single session of sequential pneumatic compression (SPC).MethodsFollowing intradermal microdoses of indocyanine green (ICG) as a lymphatic contrast agent, NIRFLI was used in a pilot study to image the lymphatics of 12 subjects with active venous leg ulcers (Clinical, Etiologic, Anatomic, and Pathophysiologic [CEAP] C6). The lymphatics were imaged before and after a single session of SPC to assess impact on lymphatic function.ResultsBaseline imaging showed impaired lymphatic function and bilateral dermal backflow in all subjects with chronic venous insufficiency, even those without ulcer formation in the contralateral limb (C0 and C4 disease). SPC therapy caused proximal movement of ICG away from the active wound in 9 of 12 subjects, as indicated by newly recruited functional lymphatic vessels, emptying of distal lymphatic vessels, or proximal movement of extravascular fluid. Subjects with the longest duration of active ulcers had few visible lymphatic vessels, and proximal movement of ICG was not detected after SPC therapy.ConclusionsThis study provides visible confirmation of lymphatic dysfunction at an early stage in the etiology of venous ulcer formation and demonstrates the potential therapeutic mechanism of SPC therapy in removing excess fluid. The ability of SPC therapy to restore fluid balance through proximal movement of lymph and interstitial fluid may explain its value in hastening venous ulcer healing. Anatomical differences between the lymphatics of longstanding and more recent venous ulcers may have important therapeutic implications.
Project description:IntroductionCompression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise.Methods and analysisThe Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective.Ethics and disseminationThe Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page.Trial registration numbersAustralia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).
Project description:High prevalence of non-healing chronic wounds contributes to a huge healthcare burden across the world. Early treatment interventions for non-healing wounds are vital. It was previously shown that accumulation of 15% or more of senescent cells in a chronic wound edge is an indicator that the wound is unlikely to heal. However, determining the presence of senescent cells would require invasive procedures such as tissue biopsies to be taken. In this study, we found a strong correlation between decreased collagen area and presence of senescent cells in human chronic wounds i.e. venous leg ulcer (VLU), diabetic foot ulcer (DFU) and pressure ulcer (PRU). We also report that the lowest collagen levels were found in VLU patients less than 60 years of age, with a persistent wound of > 24 months. Elevated levels of senescent cells were also found in VLU of males. Second harmonic imaging of collagen at the edge of chronic wounds with a handheld multiphoton device could be used to predict the number of senescent cells, indicating if the wound is on a healing trajectory or not. Our data support the use of collagen imaging in cutaneous wound assessment for a faster and non-invasive method to predict cellular senescence and determining wound trajectory of healing.