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体外冲击波治疗下肢静脉性溃疡

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研究背景

小腿部的溃疡由于血流不畅,是需要很长时间才能愈合的慢性伤口。静脉中积聚的血液会损害皮肤及周围组织,从而导致溃疡形成。腿部的静脉溃疡与生活质量下降、活动能力下降、疼痛、压力和尊严的丧失有关。下肢静脉性溃疡的标准治疗方法是压力绷带或长袜。冲击波疗法可以通过促进血管生成(血管的形成和生长)和减少炎症来帮助这些伤口的愈合,尽管这一疗法目前还知之甚少。

研究目的

旨在评价体外冲击波治疗下肢静脉性溃疡的疗效。

检索策略

在2018年4月,我们检索了Cochrane创伤组专业注册库(Cochrane Wounds Specialised Register);Cochrane对照试验中心注册库(CENTRAL);Ovid MEDLINE;Ovid MEDLINE(进程内和其他非索引引文);Ovid EMBASE;和EBSCO CINAHL。我们还检索了正在进行和未发表研究的临床试验登记注册平台,并查阅了相关研究的参考文献清单,以及综述、meta‐分析、指南和卫生技术报告,以确定纳入其他未被检索到的研究。我们不限制发表语言类型,出版日期及研究地点。

标准/纳入排除标准

我们检索了所有已发表和未发表的关于评价体外冲击波疗法治疗小腿静脉性溃疡愈合有效性的随机对照试验(RCT)。

数据收集与分析

由两名研究者单独进行研究文献筛选。我们计划由两位研究者评价纳入研究的偏倚风险,提取研究资料,使用GRADE工具对证据的等级进行评价。

主要结果

我们没有找到符合本系统综述纳入标准的RCT试验。

作者结论

我们尚没有发现评价体外冲击波治疗下肢静脉性溃疡疗效的RCT。这一领域缺乏高质量的证据,凸显了该领域的研究空缺,并证明需要进一步的研究,以便提供关于对这种疾病治疗的指导方案的证据。今后的试验研究应设计明确,并同时包括使用当前最佳的治疗方案、多层加压治疗。招募的患者应尽可能是临床实践中具有代表性的病人,并在研究设计中报告与病人相关的结局。

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

体外冲击波治疗下肢静脉性溃疡

本系统综述的目的是什么

本系统综述的目的是为发现体外冲击波疗法(类似于声波的能量脉冲,通过垫子传送到皮肤)是否有助于治愈腿部静脉性溃疡。Cochrane的研究人员寻找相关研究(随机对照试验)来回答这个问题,但是没有发现相关的研究。

主要信息

我们没有获得关于评价体外冲击波疗法(ESWT)治疗小腿静脉性溃疡是否有效的随机对照试验的证据。随机对照试验医学研究是将患者随机分配接受不同治疗方法。这种试验类型可提供最可靠的证据,目前缺乏这方面的高质量证据。

本系统综述研究了什么?

小腿溃疡是需要很长时间才能愈合的的慢性伤口。腿部静脉溃疡是由腿部血液循环不良引起的。静脉中积聚的血液会损害皮肤及周围组织,从而导致溃疡形成。腿部静脉溃疡和生活质量下降、活动能力下降、疼痛、压力和尊严的丧失有关。下肢静脉性溃疡的标准治疗方法是压力绷带或长袜。

ESWT(体外冲击波)最初是用来分解肾结石和胆结石的,但现在用于治疗肌腱炎和其他关节和肌肉疾病。ESWT还被认为可以通过刺激循环、促进健康血管的生长和减少炎症来帮助伤口愈合。这是一种治疗下肢静脉溃疡的新疗法。

本系统综述的主要结果是什么?

我们没有找到用ESWT治疗腿部静脉性溃疡的随机对照试验。这突显出医学证据上的空缺,这也证明对这个领域有必要进一步研究。

本系统综述的时效性如何?

我们检索的截至日期是2018年4月。

Authors' conclusions

Implications for practice

We found no randomised controlled trials (RCTs) to determine the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration. There is an absence of high‐quality research regarding the effects of this treatment option for this condition.

Implications for research

We found no RCTs assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration. The role of shock wave therapy as a primary treatment or adjuvant to best practice in routine care remains unclear and requires further assessment. Non‐randomised studies report generally positive outcomes and an absence of adverse events, which suggests that an RCT focusing on venous ulceration alone would be justifiable. Poor reporting of study methodology is detrimental to the validity of the existing knowledge base. Prospective studies focusing on the treatment of venous ulceration should be of clear technique and design; this would ideally include concomitant use of the current best practice treatment, multilayer compression therapy. Recruitment should aspire to best represent patients seen in clinical practice. Patient‐related outcome measures (PROMs), specifically quality of life assessment, are underreported and should be included in study design. Cost analysis should also be considered.

Background

Description of the condition

Leg ulcers are chronic wounds most commonly described as open lesions of the skin occurring below the knee on the leg or foot, further characterised by healing times of greater than six weeks (SIGN 2010; Van Gent 2010). The causes of leg ulceration are varied and often multifactorial; primary reasons for the development of a leg ulcer include venous insufficiency, arterial insufficiency and diabetes (Mekkes 2003).

Venous ulceration is the most common type of leg ulceration seen in the community. Studies have shown that for people with chronic leg ulcers, 70% to 80% of those ulcers have a venous component (Valencia 2001; Crane 2008). Chronic venous leg ulceration has an estimated prevalence of 1% to 2% of the population in developed countries. Point prevalence for the United Kingdom (UK) is estimated to be between 0.3% and 0.5% (per 1000 population), which increases with age (Reichenberg 2005; Vowden 2009; González‐Consuegra 2011). The natural history of the disease is one of a continuous cycle of healing and breakdown over decades (Smith 2006; Raju 2010).

Venous ulceration is associated with impaired quality of life, reduced mobility, pain, stress and loss of dignity (Persoon 2004; Wilson 2004). Social isolation can be commonplace and is frequently associated with malodorous wounds, swelling and anxiety around exudate levels (fluid seeping from wounds) (Walters 1999; Herber 2007).

Venous ulcers arise as a result of venous valve incompetence and calf muscle pump insufficiency (Palfreyman 1998; Mekkes 2003), which leads to retrograde venous flow, venous hypertension, microcirculatory skin changes and localised tissue damage. Two main mechanisms have been proposed to account for the tissue damage and subsequent ulceration that occurs. The fibrin cuff hypothesis postulates that venous hypertension leads to exudation of fibrin, a protein involved in the clotting of blood, into the surrounding tissues, and leads to the formation of fibrin cuffs around capillaries which impairs gas exchange, leading to tissue damage (Smith 2006). The leucocyte‐ (white blood cell) trapping hypothesis postulates that leucocytes which have become trapped in the microcirculation migrate into surrounding tissues and lead to an inflammatory response with impairment of normal proliferation and skin healing (Saharay 1998; Hahn 1999).

The current gold standard in the management of chronic venous leg ulcers revolves around high compression multilayer bandaging (SIGN 2010). Multilayer compression bandaging aims to improve venous return and reduce venous hypertension (Valencia 2001; Etufugh 2007). Elastic multi‐component bandages such as four layer bandaging and comparative two‐layer systems are used. These consist of an initial layer of orthopaedic wool, a crepe bandage, an elastic bandage and an elastic cohesive bandage as the outer layer (Marston 1999). The high pressure is sustained for a considerable time, allowing for a weekly change of dressings. With multilayer compression therapy, healing rates of around 70% at six months have been achieved in specialist clinics. Simple, nonadherent primary wound dressings are currently recommended in conjunction with compression bandaging (SIGN 2010). Other known treatments for this condition include the use of various impregnated primary dressings, hyperbaric oxygen therapy and treatment of underlying venous insufficiency via surgery, endovenous laser (EVLT), radiofrequency (RFA) and sclerotherapy treatments.

Description of the intervention

Extracorporeal shock waves (ECSWs) are low‐energy pulse waves that were first put to clinical use in the treatment of urolithiasis, whereby kidney stones (urinary calcinosis) are broken up by the shock wave energy (Shrivistava 2005). Since then their application has been extended to the treatment of fractured bones with an interrupted healing process (non‐union fractures), tendon injury and osteonecrosis, a condition whereby bone breaks down faster than it can be replenished (Schaden 2007).

More recently, the ability of ECSWs to improve the healing of wounds, ulcers and burns has been assessed. The incidental discovery that shock waves may have an effect upon wound healing was made in 2006 (Schaden 2007; Arnó 2010; Mittermayr 2011); the treatment in this context has remained novel.

Shock waves carry energy, have a short life cycle and are able to travel through a physical medium such as liquid or gas. Shock waves are generated through the transformation of electric energy into mechanical energy. This transformation can occur in one of three ways: electromagnetic generation utilises a strong magnetic field to create a slow, low‐pressure acoustic pulse (sound wave pulse); piezoelectric generation relies upon the rapid contraction and expansion of crystals via the application of a high voltage charge to achieve an acoustic pulse; and electrohydraulic utilises a shock wave pulse released by high voltage electrode water vaporisation (Ogden 2001; Mouzopoulos 2007).

Shock waves are defined by their waveform, number and frequency of impulses, and energy flux density (the rate at which energy is transferred through the physical medium). Standardised, disease‐specific protocols pertaining to the use of shock wave therapy in wound care are lacking (Schaden 2007). In the treatment of wounds, lower flux densities are typically used, providing lower energy levels. Regardless of their characteristics or mode of generation, shock waves can be delivered to a target area either in a focused or dispersed manner through the use of specific applicator units (Mittermayr 2011). All three modes of shock wave generation are found in current clinical practice. Both focused and un‐focused (dispersed) applicator units have been utilised in the delivery of treatment for soft tissue wounds, with typical energy levels of 0.037 mJ/mm2 to 0.1 mJ/mm2 (Schaden 2007; Saggini 2008). The use of shock waves in the treatment of soft tissue wounds is currently rare in the UK, with most use found in central European countries and the US.

How the intervention might work

In humans, ECSWs have been shown to promote the formation and development of blood vessels (angiogenesis) and to reduce inflammation (Wang 2011b).The mechanism of how ECSW therapy may aid wound healing is poorly understood at present, however several animal model studies have shown increased levels of signal proteins (vascular endothelial growth factor (VEGF) and factor HIF‐1alpha) following treatment. These proteins are in part responsible for the restoration of tissue oxygen supply when blood circulation is inadequate (Chen 2004; Nishida 2004; Wang 2004; Ma 2007). This angiogenic process is stimulated by the application of ESCWs and plays an important role in wound healing (Stojadinovic 2008; Mittermayr 2011).

Why it is important to do this review

Venous ulceration is a common, chronic condition resulting in significantly impaired quality of life and substantial burden to all healthcare systems. The use of shock waves in the treatment of venous leg ulcers is a novel therapy; a comprehensive review of all relevant and available randomised controlled trials is required to inform practice.

Objectives

To assess the effects of extracorporeal shock wave therapy on the healing and management of venous leg ulceration.

Methods

Criteria for considering studies for this review

Types of studies

Types of studies considered included randomised controlled trials (RCTs). We made no restrictions on the basis of language, publication status or age range.

Types of participants

We planned to include people over the age of 18 years, from any care setting and socio‐economic background, with active lower limb ulceration of venous aetiology. Guidelines in the UK indicate assessment of ankle brachial indices should be performed to rule out arterial disease, and many diagnostic assessments also include duplex ultrasound imaging to identify venous reflux (SIGN 2010); we planned to accept studies in which a diagnosis of venous ulceration had been made irrespective of whether the ankle brachial indices were reported. We planned to include studies where lower limb venous ulceration was either the focus of the study or was included within a study evaluating a broader range of soft tissue wounds. In the case of the latter, we would have stratified the results according to wound aetiology.

Types of interventions

We planned to include studies evaluating the use of low energy, focused or non‐focused extracorporeal shock waves (ECSWs) in the context of venous ulcer treatment.

Eligible comparators would have included:

  • ECSW compared with no treatment or sham treatment;

  • ECSW compared with dressings (with or without compression treatment);

  • ECSW compared with alternative treatment, for example truncal venous surgery (including endovenous laser treatment, radiofrequency and sclerotherapy), hyperbaric oxygen therapy;

  • head‐to‐head comparisons of varying types, modes and strengths of ECSW treatment.

Shock waves produced by any of the three accepted methods were considered for inclusion; these comprise electrohydraulic, electromagnetic and piezoelectric principles of shock wave generation. We would have excluded studies examining ECSW use for the treatment of chronic tendinopathies, impaired bone healing function, urinary and biliary clacinosis and myocardial ishchaemia.

Types of outcome measures

Primary outcomes

Complete wound healing measured by:

  • time to complete wound healing;

  • proportion of index ulcers completely healed;

  • adverse effects, including participant‐reported pain from intervention (measured using a visual analogue scale, such as a numeric box scale (NBS).

Secondary outcomes

  • Change in ulcer size (percentage change from baseline)

  • Quality of life (measured using a standardised generic questionnaire such as EQ‐5D, SF‐36, SF‐12 or SF‐6)

  • Volume of exudate (utilising subjective measurement, such as low, medium, high)

  • Daily ulcer pain (measured using a visual analogue scale, such as an NBS)

  • Ulcer recurrence (defined as a new lesion in the skin where complete healing had occurred)

  • Treatment cost

Search methods for identification of studies

Electronic searches

We searched the following electronic databases to identify reports of relevant clinical trials:

  • the Cochrane Wounds Specialised Register (searched 4 April 2018);

  • the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library (searched 4 April 2018);

  • Ovid MEDLINE including In‐Process & Other Non‐Indexed Citations (1946 to 4 April 2018);

  • Ovid Embase (1974 to 4 April 2018);

  • EBSCO CINAHL Plus (1937 to 4 April 2018).

The search strategies for the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus can be found in Appendix 1. We combined the Ovid MEDLINE search with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and precision‐maximising version (2008 revision) (Lefebvre 2011). We combined the Embase search with the Ovid Embase filter developed by the UK Cochrane Centre (Lefebvre 2011). We combined the CINAHL Plus searches with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2018). We applied no restrictions with respect to language, date of publication or study setting.

We also searched the following clinical trials registries:

Search strategies for clinical trial registries can be found in Appendix 2.

Searching other resources

We examined the reference lists of all identified, relevant studies in order to locate further studies not highlighted by the electronic search.

Data collection and analysis

Data collection and analysis were carried out according to methods stated in the published protocol (Cooper 2015), which were based on the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Selection of studies

Two review authors (BC, PB) independently assessed studies for potential inclusion. They examined references drawn from initial searches for relevance; studies considered for inclusion were retrieved in full and selected according to the criteria for considering studies for this review described above.

We have included a study flow diagram as recommended by the PRISMA statement (Liberati 2009), to illustrate the results of all searching activity and the process of screening and selecting studies for inclusion in the review.

Data extraction and management

Had we identified eligible studies, two review authors (BC, PB) would have independently used a data extraction sheet to summarise studies. In cases where multiple publications had arisen from a study, we would have identified one publication as the primary reference but all studies would have been maximally data extracted.

We intended to extract the following data:

  • trial authors;

  • year of publication;

  • country where RCT performed;

  • care setting;

  • unit of investigation (participant, leg or ulcer);

  • overall sample size and methods used to estimate statistical power;

  • participant selection criteria;

  • number of participants randomised to each treatment arm;

  • baseline characteristics of participants per treatment arm (gender, age, baseline ulcer area and volume, ulcer duration, prevalence of comorbidities such as diabetes, prevalence of clinically infected wounds or colonised wounds, previous history of ulceration, baseline levels of wound exudate, and participant mobility);

  • details of the dressing/treatment regimen prescribed for each treatment arm including details of concomitant therapy (for example: compression);

  • duration of treatment;

  • duration of follow‐up;

  • statistical methods utilised in data analysis;

  • primary and secondary outcomes measured;

  • primary and secondary outcome data by treatment arm;

  • adverse effects of treatment (per arm with quantity and type);

  • withdrawals (per treatment arm with quantity and reason);

  • source of trial funding.

Assessment of risk of bias in included studies

Had studies met our inclusion criteria, two review authors (PB, BC) would have independently assessed each included study using the Cochrane tool for assessing risk of bias (Higgins 2011). This tool addresses six specific domains: sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other potential sources of bias (for this review, baseline comparability of groups for factors such as surface area and duration of ulcer). We planned to classify included RCTs as being at an overall high risk of bias if they were rated as 'high risk' for any one of three key domains: allocation concealment, blinded outcome assessment of healing, and completeness of outcome data. We would have classified RCTs as having an overall low risk of bias if rated as 'low risk' in the three key domains of allocation concealment, blinded outcome assessment of healing, and completeness of outcome data.

We would have made individual assessments of participant blinding and blinding of outcome assessors in included studies. We planned to present our assessment of risk of bias using two 'Risk of bias' summary figures; one which is a summary of bias for each item across all studies, and a second which shows a cross‐tabulation of each trial by all of the 'Risk of bias' items.

Measures of treatment effect

We planned to perform data analysis according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). One review author would have entered quantitative data into Review Manager 5, another would have checked it. We would have analysed the data using RevMan 5 (Review Manager 2014). We planned to present the outcome results for each trial with 95% confidence intervals (CI).

We hoped to report estimates for dichotomous outcomes (e.g. ulcers healed during time period, number of infected ulcers) as risk ratios (RR).

We would have expressed continuous outcomes (such as changes in ulcer area) as mean differences (MD) and overall effect size (with 95% CI calculated) or as standardised mean differences (SMDs) if different methods of measurement had been used in the studies.

We planned to analyse time‐to‐event data utilising survival, time‐to‐event approaches, with adjustment for baseline size if data had been available. We also planned to plot, and if feasible, pool, estimates of hazard ratio and 95% CI as presented in the trial reports using the generic inverse variance method in Review Manager 5. Time‐to‐event data incorrectly reported (as mean and standard deviation, SD) would not have been analysed but instead discussed separately within the review.

Unit of analysis issues

Had studies met our inclusion criteria, we would have recorded whether these studies presented outcomes in relation to a wound, a participant or as multiple wounds on the same participant. We would also have analysed the level at which study randomisation had occurred.

Dealing with missing data

Had we identified any studies which met our inclusion criteria, we would have attempted to contact the trial investigators in cases of missing data. Should trials have reported complete healing outcomes for only those participants who completed the trial (i.e. participants withdrawing and lost to follow‐up were excluded from the analysis), we would have treated the participants who were not included in the analysis as if their wound did not heal. Should trials have reported results for participants who completed the trial without specifying the numbers initially randomised per group, we would have presented only complete case data. For other outcomes the same analysis would have been applied.

Assessment of heterogeneity

We intended to consider clinical heterogeneity (where trials appear different in terms of participant characteristics, intervention type, duration and outcome type) and statistical heterogeneity. We planned to assess statistical heterogeneity using the Chi2 test (P values less than 0.10 would have been considered to indicate significant heterogeneity) in conjunction with the I2 statistic (Higgins 2003). The I2 statistic estimates the percentage of total variation across trials due to heterogeneity rather than variation due to chance. We would have categorised heterogeneity as follows: I2 values of 40% or less would have indicated a low level of heterogeneity, and values of 75% or above would have represented very high heterogeneity.

Assessment of reporting biases

If possible, we would have used funnel plots to assess reporting bias if a minimum of 10 studies were available for the meta‐analysis of a primary outcome (Sterne 2011).

Data synthesis

We would have combined details of included studies in a narrative review according to type of comparator, possibly by location/type of wound and then by outcomes by time period. We would have considered clinical and methodological heterogeneity and undertaken pooling when studies appeared appropriately similar in terms of wound type, intervention type, duration of follow‐up and outcome type.

We were unable to pre specify the amount of clinical, methodological and statistical heterogeneity included studies but it might have been extensive. Thus, we anticipated using a random‐effects approach for meta‐analysis. Conducting meta‐analysis with a fixed‐effect model in the presence of even minor heterogeneity may provide overly narrow confidence intervals. We would only have used a fixed‐effect approach when clinical and methodological heterogeneity was assessed to be minimal, and the assumption that a single underlying treatment effect is being estimated held. We would have used Chi2 and I2 to quantify heterogeneity but the results of this would not have been used to guide choice of model for meta‐analysis. We would have exercised caution when meta‐analysed data were at risk of small study effects, because a random‐effects model may be unsuitable. In this case, or where there were other reasons to question the selection of a fixed‐effect or random‐effects model, we would have assessed the impact of the approach using sensitivity analyses to compare results from alternate models (Thompson 1999).

We would have presented data using forest plots where possible. For dichotomous outcomes we would have presented the summary estimate as a risk ratio (RR) with 95% CI. Where continuous outcomes were measured in the same way across studies, we planned to present a pooled mean difference (MD) with 95% CI; we planned to pool standardised mean difference (SMD) estimates where studies measured the same outcome using different methods. For time‐to‐event data, we planned to plot (and, if appropriate, pool) estimates of hazard ratios and 95% CIs as presented in the study reports using the generic inverse variance method in Review Manager 5. Where time to healing was analysed as a continuous measure but it was not clear if all wounds healed, we would have documented the use of the outcome in the study but would not have summarised the data in any meta‐analysis.

We would have obtained pooled estimates of treatment effect using Review Manager 5.

'Summary of findings' tables

We had planned to present the main results of the review in 'Summary of findings' tables. Had we identified eligible studies, these tables would have presented key information concerning the quality of the evidence, the magnitude of the effects of the interventions examined, and the sum of the available data for the main outcomes (Schünemann 2011a). The 'Summary of findings' tables would also have included an overall grading of the evidence related to each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach. The GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the true quantity of specific interest. The quality of a body of evidence involves consideration of within‐trial risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias (Schünemann 2011b).

We had planned to present the following outcomes in the 'Summary of findings' tables:

  • time to complete wound healing;

  • proportion of index ulcers completely healed over a six month period;

  • adverse effects, including participant‐reported pain from intervention (measured using a visual analogue scale, such as a numeric box scale (NBS).

Subgroup analysis and investigation of heterogeneity

Had we identified studies for inclusion in the review, we would have considered potential sources of heterogeneity and made every effort made to extract sufficient, compatible data to undertake subgroup analysis of individuals. Subgroups may have included demographic divisions, variations in type of shock wave treatment and differing durations of follow‐up.

Sensitivity analysis

We had planned to undertake sensitivity analyses to explore the influence of risk of bias on effect size. We would also have assessed the influence of removing from meta‐analyses, studies classed as having an overall high risk of bias. These analyses would have included only studies that were assessed as having a low risk of bias in all key domains, namely allocation concealment, blinded outcome assessment of healing, and completeness of outcome data for the estimates of treatment effect.

Results

Description of studies

Results of the search

See Figure 1.


Study flow diagram.

Study flow diagram.

We found and assessed 218 titles and abstracts in electronic format through searches of the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus. In addition, we identified a further 17 titles and abstracts through searches of clinical trial registries (ClinicalTrials.gov and WHO International Clinical Trials Registry Platform). Of these 235 records, we excluded 230 after initial review; we excluded the remaining five studies after reviewing the full text, and concluded that no studies met our inclusion criteria.

Included studies

We found no eligible studies.

Excluded studies

We excluded five randomised controlled trials (RCTs) as we deemed them irrelevant to the focus of this review; these studies are described in the Characteristics of excluded studies section. Of the five excluded studies, all met the inclusion criteria for relevant intervention being studied, but they did not include venous ulceration as a condition within the study.

Risk of bias in included studies

As we identified no eligible studies, it was not possible to assess risk of bias.

Effects of interventions

We found no eligible studies for inclusion.

Discussion

Summary of main results

Despite an extensive search of the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, the World Health Organization (WHO) International Clinical Trials Registry and ClinicalTrials.gov, we did not find any studies that met the inclusion criteria for this review. We excluded studies where the intervention met inclusion criteria but the subject of the study did not include ulceration of venous aetiology.

Overall completeness and applicability of evidence

We found no randomised controlled trials (RCTs) assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration.

Quality of the evidence

We found no studies conducted to address our objectives; therefore, we were unable to assess the quality of the evidence.

Potential biases in the review process

We found no studies relevant for inclusion in this review. We performed a comprehensive search of the literature, and performed study selection in accordance with recommendations provided in the Cochrane Handbook for Systematic Reviews of Interventions (Lefebvre 2011). In addition to our primary search, we also searched clinical trial registries (ClinicalTrials.gov and WHO International Clinical Trials Registry Platform) and again, we found no relevant studies for inclusion in this review. We considered the evidence available; however it is possible that there may be unpublished data that we were unable to access. There is limited potential for publication bias.

Agreements and disagreements with other studies or reviews

Several published literature reviews regard shock wave therapy for wound healing as safe, with potential for further investigation (Qureshi 2011; Mittermayr 2012). However, few of the incorporated studies include venous ulceration and reviews rely upon non‐randomised trials or case series reports, rather than randomised controlled trials.

Favourable outcomes are reported in several non‐randomised studies of shock wave therapy, most notably in: 'Shock wave therapy for acute and chronic soft tissue wounds: a feasibility study' and 'Extracorporeal shock wave therapy for the management of chronic ulcers in the lower extremities' (Schaden 2007; Saggini 2008). Both studies include venous ulceration. Whilst this type of evidence may be of some use in decision making, it lacks the rigour of a randomised controlled trial. Randomised controlled trials which examine extracorporeal shock wave therapy for generalised soft tissue wounds exist, but none met the inclusion criteria for this review because they did not specifically identify venous insufficiency as wound aetiology.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.