The comparative impact of conservative treatment versus superficial venous surgery,for the treatment of venous leg ulcers: A systematic review of the impact on patients’ quality of life

Abstract

Objectives

Leg ulcers are known to have a profound effect on patients’ quality of life; however, the influence of different treatment approaches is unclear. This review aims to evaluate the comparative impact of conservative treatments and superficial venous surgery, for venous leg ulcers, on patients’ Quality of Life.

Data sources

Three electronic databases (PsycInfo, Medline and CINAHL), and reference lists of relevant articles, were searched. A total of 209 articles were initially identified, and 16 articles were included in the review.

Results

The results lend cautious support to the suggestion that all treatments have a positive effect on quality of life, regardless of type, whilst wound status also appears to be an important factor.

Conclusions

Some evidence suggests that surgical treatment methods may lead to greater improvements in patients’ quality of life than compression bandaging alone; however, future research may focus on the psychological mechanisms underlying such changes.

Keywords

Venous ulceration compression quality of life assessment vascular surgery

Introduction

Venous leg ulcers are the most common type of leg ulcer in the UK, and account for approximately 80–85% of all leg ulcers.¹ Approximately, 1% of the UK population will suffer from a venous leg ulcer at some point in their lives, whilst 0.1–0.3% of the population has an open leg ulcer at any one time.² Qualitative and quantitative reviews of the literature suggest that people with leg ulcers experience a negative impact on their daily life, specifically regarding their physical health, social well-being, and psychological well-being.³ A review has suggested that leg ulcers may result in more pain, less mobility, poorer psychological well-being, and poorer social interaction for sufferers, when compared to their healthy counterparts,⁴ representing a profound effect on an individual’s quality of life.

Venous leg ulcers are commonly treated in the community with compression bandaging or advanced wound dressings; however, ulcers often take a long time to heal and recurrence rates are high.⁴ More recently developed treatment methods include surgical interventions, such as superficial venous surgery, that aim to address the underlying cause of the venous leg ulcers. Evidence suggests that this surgery reduces rates of recurrence and may be effective at healing venous leg ulcers.⁵ The ESCHAR trial, a prominent multi-centre randomised controlled trial, found no significant differences between healing rates in superficial venous surgery and compression, versus compression alone (p = .73); however, they did find a significant difference in recurrence rates at 4 years (p < .01) and more ulcer free time after 3 years in the surgical group (p = .007)⁶. The comparative impact of this surgery on patients’ quality of life, however, remains unclear.

Several review articles have investigated the comparative effectiveness of treatment approaches, and included their effect on patients’ quality of life. One such review⁷ investigated the comparative effectiveness of various advanced wound dressings versus compression bandaging alone, including biological and quality of life outcomes. The authors drew some cautious conclusions about the differential impact on healing, but they were unable to provide any conclusions about the impact on quality of life, due to scarcity and heterogeneity of research regarding this outcome measure. A second review examined the comparative effectiveness of surgical interventions aimed at treating the underlying venous pathology.⁸ Similarly, however, only two studies included in their review had collected data on quality of life, so once again no conclusions were offered regarding this outcome measure.

As the primary outcomes examined these reviews were medical, their inclusion criteria were strict with regards to these clinical elements.^7,8 This was necessary for the focus of their reviews, to determine those articles with best clinical and research practice; however, few of these studies were found to include quality of life outcomes. The present systematic review is being conducted with a psychological focus, and aims to expand the inclusion criteria to allow a wider spectrum of studies to be examined, including more studies investigating quality of life. This will enable conclusions to be drawn regarding the impact of such interventions on quality of life. Such a review is thought to be necessary as the literature varies widely in many aspects, including the populations studied, outcomes investigated and research designs employed. A systematic review of this nature will allow a coherent narrative of the existing literature, providing insight into the impact of various treatments on quality of life and suggesting ways in which future research might build upon the existing literature.

In light of existing reviews and literature, the aim of this systematic review is to investigate the comparative impact of bandaging/compression treatments and superficial venous surgery for venous leg ulcers on patients’ quality of life. This review will focus on quality of life as the primary outcome measure, differentiating it from other similar reviews in this area. In order to meet this aim, and guided by existing literature, this review will focus on three hypotheses:

Both bandaging/compression treatments and superficial venous surgery for venous leg ulcers will lead to improvements in patients’ quality of life.

Patients’ quality of life will be impacted to differing extents depending on the treatment type.

Patients’ quality of life will be influenced by wound status.

Method

This systematic review aimed to evaluate the comparative impact of bandaging/compression treatments and superficial venous surgery on venous leg ulcer patients’ quality of life. A systematic search of three electronic databases was completed in May 2014 to identify relevant research studies. A comprehensive search strategy was developed and utilised with PsycInfo, Medline and CINAHL electronic databases. Search terms within this strategy included: ‘Venous leg ulcer*’, treat*, intervention*, compression, surg*, ‘quality of life’, QOL and HRQOL. An electronic alert was set-up to notify researchers of newly published search results and this continued until August 2014.

The primary author performed an initial screening of search findings, with aid from the other authors in further review of the articles. The following criteria were employed when reviewing potential articles for inclusion in this review:

Articles must contain original data; therefore, no review articles were included.

Articles must include quantitative methods; studies with a mixed-methods design were included if the quantitative data were presented separately from the qualitative data and had been statistically analysed.

Participants must have/had leg ulcers, specifically venous leg ulcers. If participant’s ulcers were of a mixed aetiology, at least 50% of participants in the study must have had venous leg ulcers.

Studies must have investigated the effect of a either a bandaging/compression-based treatment or superficial venous surgery, with the aim of healing/curing the venous leg ulcer. Interventions aimed only at, for example, reducing pain or improving adherence to another treatment were excluded.

Studies must have explicitly measured patient’s ‘quality of life’ or ‘health related quality of life’, either at multiple time points or in multiple conditions.

A total of 206 articles were initially identified in the search and underwent ‘title review’. This initial screening excluded 113 articles for irrelevance or ineligibility according to the inclusion criteria. Abstracts of the remaining 93 articles were subsequently reviewed, at which point a further 65 articles were excluded due to irrelevance or ineligibility. Full text articles were obtained for the remaining 28 studies, at which point 15 were excluded due to violation of the inclusion criteria (see Figure 1) and 13 were included in the review. Once a final list of eligible studies had been identified, reference lists of these articles were hand-searched for relevant studies and a further three articles were identified and obtained as a result. Therefore, a total of 16 articles were included in this review.

Figure 1.

Flow chart to demonstrate review progression and article inclusion/exclusion.

Results

Study characteristics

For a descriptive summary of all 16 studies included in the review, see Table 1.

Table 1.

Descriptive summary of all studies included in the review.

Authors	Inte. method(s)	Study design	Follow-up period	Quality of Life (QOL) measure(s)	QOL data reported	Hypothesis 1: QOL improvements as a result of treatment	Hypothesis 2: Differences in QOL improvements between treatments	Hypothesis 3: Relationship between QOL and Wound status outcomes
Brizzio et al.²³	1: Low-strength compression stockings 2: Traditional bandages	Randomised controlled trial (n = 55)	13 weeks	CIVIQ (Spanish version) – measured at 0, 4, 8 and 13 weeks	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✗	–	No significant differences were found between treatments (p > .05)	Physical (p = .001), social (p = .02) and psychic (p = .003) dimensions of QOL had significantly improved in healed patients, but not unhealed patients. Pain (p < .001) and the CIVIQ total score (p < .001 healed, p = .03 unhealed) significantly improved in both healed and unhealed participants
Charles¹²	Short-stretch bandages	Non-randomised controlled trial. Data compared with age-equivalent norms (AEN). (n = 65)	12 weeks	SF-36 – measured at study entry, and either study exit (12 weeks) or upon complete wound closure	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✗	Statistically significant improvements were found in patient reports of bodily pain (p < 0.001), social functioning (p < 0.005), mental health (p < 0.011), and the health transition score (p < 0.001) between study entry and exit	–	In those patients whose ulcers healed, four domains of QOL (bodily pain, vitality, social functioning and mental health) improved significantly between entry and exit In those patients whose ulcers did not heal, only bodily pain significantly improved between entry and exit
Clarke-Moloney et al.⁹	1: Four-layer compression bandaging 2: Continuation of usual care	Randomised controlled trial (n = 200)	Six weeks	SF-36 and CIVIQ – measured at entry and after six weeks of treatment in patients whose wound remained unhealed	Mean? ✗ SD? ✗ p-Value? ✓ Effect size? ✗		Four-layer bandaging group participants reported improved and significantly different QOL scores from the control group in physical activity (p = 0.006), social functioning (p = 0.001) and global index domains (p = 0.006) of the CIVIQ; and the physical functioning (p = 0.0001) and role-physical (p = 0.006) elements of the SF-36 measure	–
Finlayson et al.¹⁹	1: Four-layer compression bandaging 2: Class 3 compression hosiery	Randomised controlled trial (n = 103)	Twenty-four weeks	QL Index, Geriatric Depression Scale and MOS Pain Severity Scale – measured at baseline, 12 weeks and 24 weeks	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✓	No significant improvements were found in QL Index scores (p = 0.223); however, improvements were found in the Geriatric Depression Scale scores (p = 0.035) and MOS Pain scores (p < 0.001)	No significant differences were found between treatment groups (p > 0.05)	–
Franks and Moffatt¹⁸	High compression bandaging	Non-randomised controlled trial (n = 383)	Twelve weeks	Nottingham Health profile (NHP) – measured upon study entry and exit	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✗	Quality of Life was found to improve significantly in all domains of the NHP after 12 weeks of treatment (p = <0.009)		Significant differences between participants with unhealed and healed ulcers were found in the domain of bodily pain (p = 0.004)
Franks et al.¹³	1: ‘Generic four-layer bandaging system’ 2: A cohesive short-stretch system	Randomised controlled trial (n = 156)	Twenty-four weeks	Nottingham Health profile (NHP) – measured at baseline, at healing/withdrawal and after 24 weeks	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✓	The total patient group reported statistically significant improvements in all domains of the NHP after 24 weeks (p ≤ 0.001)	No differences were found in HRQOL between the two treatment groups (p ≥ 0.32)	Participants with unhealed ulcers showed no significant differences in any of the NHP domains after 24 weeks (p ≥ 0.54), while participants whose ulcers did heal showed significant differences in all domains (p ≤ 0.001)
Franks et al.¹⁴	1: Old generation four-layer bandage system 2: New generation four-layer bandage system	Randomised controlled trial (n = 232)	Twenty-four weeks	Nottingham Health profile (NHP) – measured at baseline, 12 and 24 weeks of treatment	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✓	QOL was reported to improve in both treatment groups	No significant differences were found between treatments (p ≥ 0.34)	Differences were found between healed and unhealed participants on bodily pain (p = 0.023) and sleep (p = 0.007) domains of the NHP
Guest et al.¹⁵	1: Four-layer bandaging only 2: Superficial venous surgery and four-layer bandaging	Randomised controlled trial (n = 76)	Twenty-four weeks	SF-36 and Charing Cross Venous Ulcer Questionnaire	Mean? ✓ SD? ✗ p-Value? ✓ Effect size? ✗	The CCVUQ measure showed significant improvements over time for the surgical treatment group, at three and six months (p < 0.05), and significant improvements for the compression treatment group at 6 months (p < 0.05)	No significant differences were found between groups at any timepoint using the CCVUQ (p > 0.05)	Patients with healed ulcers at 24 weeks reported significantly better HRQOL than participants whose ulcers had not healed (p < 0.05)
Harding et al.²¹	1: Adaptive Compression Therapy (ACT) device 2: Four-layer bandage system	Randomised controlled trial (n = 90)		EuroQol-5D – measured at baseline and study completion	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✗		Multi-variable linear regression modelling predicted final QOL scores, suggesting a significantly higher index score for ACT than 4-layer bandaging (0.1025, p = 0.0375)	Multi-variable linear modelling predicted that patients with healed ulcers would have a higher index score than patients with unhealed ulcers (0.1774, p = 0.004)
Harrison et al.²⁴	1: Four-layer bandaging 2: Short-stretch bandaging	Randomised controlled trial (n = 424)	Twelve weeks	SF-12 measured at baseline	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✗	–	No significant differences were detected between groups at 3 months post baseline, on the mental component summary (p = 0.335) or the physical component summary (p = 0.675).	–
Jull et al.¹⁰	1: Honey impregnated dressings and compression bandaging 2: Usual care (including compression bandaging)	Randomised controlled trial (n = 368)	Twelve weeks	SF-36, EuroQol5D, and Charing Cross Venous Ulcer Questionnaire – measured at 12 weeks only	Mean? ✓ SD? ✗ p-Value? ✓ Effect size? ✗	–	No significant differences between groups on any of the QOL measures (p = 0.256–0.437)	–
Loftus¹⁶	1: Four-layer bandaging 2: Superficial venous surgery	Non-randomised trial (n = 30)	Twelve weeks	EuroQol 5D and author created measure – measured at pre-treatment, and four and 12 weeks post-treatment	Mean? ✓ SD? ✗ p-Value? ✓ Effect size? ✗	Quality of life improved significantly for both groups (surgery p = 0.001, bandaging p = 0.019)	No significant differences were found between treatment groups at 12 weeks (p = 0.67)	–
Michaels et al.¹⁷	1: Silver-donating dressings 2: Non-silver low adherence dressings	Randomised controlled trial (n = 213)	Forty-eight weeks	EuroQol 5D and SF-6D – measured at 1, 3, 6 and 12 months	Mean? ✓ SD? ✗ p-Value? ✗ Effect size? ✗		No significant differences were between the two treatment groups	No significant difference was found between those whose ulcers healed and those whose ulcers persisted
Moffatt et al.²²	1: Two-layer bandaging system 2: Four-layer bandaging system	Randomised controlled 8-week crossover trial (n = 83)		Cardiff Wound Impact Schedule – measured at baseline, time of crossover and study exit	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✗	–	Two-layer bandaging was associated with significantly larger improvements in the ‘physical symptoms and daily living scores of the QOL measure’ (p < 0.05) – no other significant differences were found pre- or post-crossover	–
Weller et al.²⁰	1: Three layer bandaging treatment 2: Standard inelastic compression bandage treatment	Randomised controlled trial (n = 45)	Twelve weeks	SF-36 and Cardiff Wound Impact Schedule – measured at baseline and end of treatment	Mean? ✓ SD? ✓ p-Value? ✓ Effect size? ✗	–	No statistically significant differences were found between the two treatment groups (p ≥ 0.13)	Participants whose ulcers healed had significantly higher scores on the ‘mental component summary’ of the SF-36 than those whose ulcers did not heal (p = 0.02)
Zamboni et al. ¹¹- plus erratum²⁵	1: Minimally invasive surgical haemodynamic correction of reflux (CHIVA) 2: Compression therapy	Randomised controlled trial (n = 47)		SF-36 - measured at baseline and conclusion of the study (3 years)	Mean? ✗ SD? ✗ p-Value? ✓ Effect size? ✗	Statistically significant improvements were found in 4 + domains of QOL for each treatment group (p < 0.05)	Statistically significant improvements were found in QOL across all eight measured QOL elements in the surgical treatment group and four elements in the compression group (p < 0.05). Statistically significant differences were found between the two groups in five of the measured elements: role-physical limitation, vitality, social functioning, role-emotional limitation and mental health	–

Participants

Sample size in the included studies ranged from 30 to 383 participants, with a mean of 161 participants in each study. All studies included a combination of men and women. The mean age of participants in the included studies ranged from 61.75 to 75.15 years old, with a mean of 64.38 years old across 15 of the 16 reviewed studies; one study did not provide sufficient data to be included in these mean age calculations.⁹

Of the 12 studies that provided data on participant’s ulcer duration, the mean duration of ulceration ranged between 2 and 109 months, with a mean duration across these studies of 13 months. Mean ulcer size was reported by nine studies, and this ranged from 410 mm² to 2650 mm², with an average of 1030.9 mm² across the studies. Fourteen studies reported participants with venous leg ulcers only, whilst two studies reported participants with a combination of venous and mixed venous-arterial/mixed aetiology.^10,11

Seven of the 16 included studies were conducted in the UK,^12–18 two in Australia^19,20 and two collected data across multiple countries.^21,22 Studies were also conducted in Argentina,²³ Ireland,⁹ Canada,²⁴ New Zealand¹⁰ and Italy.¹¹

Interventions

Nine studies investigated the comparative effectiveness of various types of bandaging, compression therapy, or advanced wound dressings. These included compression therapy versus bandaging,²³ three-layer bandaging versus inelastic compression,²⁰ two-layer bandaging versus four-layer bandaging,²² four-layer bandaging versus regular bandaging,⁹ four-layer bandaging versus compression hosiery,¹⁹ four-layer bandaging vs Short-Stretch bandaging,^13,24 a comparison of two generations of four-layer bandaging¹⁴ and a study investigating adaptive compression therapy (ACT) versus four-layer bandaging.²¹ This review also includes two studies examining advanced wound dressings, including a comparison of honey infused dressings and compression bandaging¹⁰ and silver donating dressings versus regular low adherence dressings.¹⁷

Three studies examined the effects of superficial venous surgery versus compression bandaging.^11,15,16

Two studies did not compare multiple interventions, but instead aimed to examine quality of life outcomes as a result of treatment in general. In these studies, high compression bandaging¹⁸ and short-stretch compression bandaging¹² were used.

Quality of life measures

Generic Health-Related Quality of Life measures included the Short Form-36 (n = 6),^9–12,15,20 Short Form-12 (n = 1),²⁴ ShortForm-6D (n = 1),¹⁷ the EuroQol-5D (n = 4),^10,16,17,21 Nottingham Health Profile (n = 3)^13,14,18 and Quality of Life Index (n = 1).¹⁹

Specific ulcer or wound-related Quality of Life measures included the Cardiff Wound Impact Schedule (n = 1),²² the Chronic Venous Insufficiency Questionnaire (n = 1),²³ the Charing Cross Venous Ulcer Questionnaire (n = 2)^10,15 and an author created measure (n = 1).¹⁶

Five studies combined one or more ‘generic’ quality of life measures with a ‘specific ulcer-related’ quality of life measure,^{9,10,15,16,20} and one study utilised two different generic Quality of Life Measures.¹⁷ The remaining 10 studies used a single generic or specific Quality of Life Measures.

Quality of data reporting

The quality of data reporting across the included papers varied, with most reporting p-values but variation in the mean values, standard deviations and effect sizes reported (see Table 1). Extensive heterogeneity was observed across the included articles, including heterogeneity of treatment method, measurement tools and time points utilised. Therefore, meta-analysis was deemed inappropriate in line with Cochrane recommendations regarding meaningful pooling of outcomes and comparable treatments,³⁰ and a detailed systematic review was conducted.

Hypothesis one: Both treatments for venous leg ulcers will lead to improvement in patients’ quality of life

Eight studies suggested that all investigated treatments lead to improvements in overall QOL regardless of treatment type.^11–19 This included compression therapy, 4-layer bandaging, 3-layer bandaging, short-stretch bandaging, advanced wound dressing, and superficial venous surgery. These results lend support to the hypothesis that treatment itself may lead to improvements in patients’ quality of life, regardless of type.

Eight studies did not provide sufficient information to contribute to this hypothesis.^{9,10,17,20–24} Many of these studies did not clearly report whether treatment had significantly improved from baseline in individual treatment groups, and sufficient data were not included for the reviewers to make these calculations. Other studies did not collect data at multiple time points and therefore could only investigate whether quality of life differed between groups post-treatment.

Hypothesis two: Patients’ quality of life will be impacted to differing extents depending on treatment type

Nine studies found no statistically significant difference in post-treatment quality of life scores between treatment groups. This included eight studies comparing various types of bandaging and advanced wound dressings^{10,13,14,17,19,20,23,24} and one study comparing quality of life as a result of superficial venous surgery versus standard bandaging.¹⁶ All nine of these studies found that quality of life was improved in both treatment conditions, but that no significant differences existed between the treatment groups.

Five studies did find statistically significant differences in quality of life scores between treatment groups. Three of these studies compared various types of bandaging, concluding that: 2-layer bandaging led to significantly larger improvements in ‘physical symptoms’ and ‘daily living’ elements of quality of life than 4-layer bandaging,²² four-layer bandaging led to better reported outcomes in ‘physical activity’, ‘social functioning’ and ‘global index’ domains than usual bandage-based care⁹ and adaptive compression therapy (ACT) was suggested to predict a significantly higher quality of life index score when compared with four-layer bandaging.²¹ Two of these five studies investigated superficial venous surgery alongside compression therapy, compared to compression therapy alone, and found that the surgical group reported significantly better quality of life in more domains of the questionnaires post-treatment than the compression-only group.^11,15

Two studies did not compare treatment types, instead examining changes in quality of life within one treated group over multiple time points.^12,18

Hypothesis three: Patients’ quality of life is influenced by wound status

Of the 16 articles included in this review, nine articles analysed data for differences in quality of life dependent on wound status. One study found no statistically significant differences in quality of life between participants with healed and unhealed leg ulcers as a result of the intervention;¹⁷ however, eight studies found significant differences in at least some domains of quality of life.^{12–15,18,20–23} These latter eight studies concluded that various domains of quality of life had significantly improved in participants whose leg ulcers had healed, whilst those with unhealed ulcers reported comparatively smaller improvements.

Two additional articles^9,11 suggested that significant differences in Quality of Life between treatment groups may be due to healing rates, although they did not statistically analyse data for differences dependent on wound status. One of these studies found that surgical treatment was associated with significant improvements in more QOL domains (p < 0.05) and improved healing rates than compression treatment.¹¹ This led the authors to suggest an association between wound status and quality of life. In addition, a second study found that participants treated with four-layer bandaging experienced higher healing rates, and significantly improved QOL in physical activity related and social functioning domains of quality of life measures (p < 0.006).⁹ This was compared to those treated with usual care bandaging, and these authors also suggested that differences may be due to wound status. Whilst these two articles did not run separate statistical analysis to investigate whether or not differences in quality of life were dependent on wound status, they do suggest in discussion of the results that this may have been the case.

Five studies did not present analysis on the relationship between wound status and quality of life.^{10,16,19,22,24} The authors of these articles were contacted for clarification or additional data. Four replied that they had no additional data or publications whilst one provided a further article. This article provided further insight regarding predictors of HRQOL in people with chronic leg ulcers, but did not, however, contribute to the specific hypotheses addressed in the current paper.²⁶

Discussion

The aim of this review was to evaluate the comparative impact of bandaging/compression treatments and superficial venous surgery on venous leg ulcer patients’ Quality of Life. Sixteen papers were identified for inclusion in this review; however, they displayed considerable heterogeneity in intervention, study design and measurement tools used. This factor, as well as a paucity of detailed data, meant that a meta-analysis was not deemed appropriate and instead a detailed systematic review was conducted.

Of the three hypotheses examined by this review, there appears to be support for all three. It appears that treatment itself may lead to improvements in patients’ quality of life, regardless of treatment type, as eight of the 16 studies included in this review suggest that all investigated treatments led to improvements in quality of life. The remaining eight studies were unclear on this point and none concluded that treatment had no impact on quality of life.

Whilst 9 of the 14 studies that compared interventions found no difference in participant’s quality of life scores between treatments, these results depended greatly on the treatment types being compared. Results suggest that many of the compression or bandaging-based treatments for venous leg ulcers may have an equivalent impact on patients’ quality of life, as only 3 of 11 studies (27.27%) found differences in quality of life outcomes between types of bandaging. In contrast, two of the three studies that investigated superficial venous surgery found significant differences in the QOL of those treated with surgery and compression therapy (versus compression therapy alone). These results lend cautious support to the hypothesis that patients’ quality of life is impacted to a differing extent dependent on treatment type, with greater improvements observed in patients undergoing superficial venous surgery.

Results regarding wound status and quality of life suggest that this may be an overarching factor when examining the effect of treatment type on patients’ quality of life. These conclusions are in contrast to some authors, who have suggested that good quality wound care and management may be more important to patients’ QOL than wound status.¹²

Research regarding other conditions has suggested that surgery might have a differential effect on QOL due to the nature of undergoing a surgical procedure,²⁷ which may explain these results. Such research suggests that healing from surgery involves active participation and evolving beyond the condition, allowing patients to seek purpose and independence.²⁷ Such a transition may not normally be possible for leg ulcer patients, due to the longevity and immobilisation of the condition;²⁸ however, surgery may allow a more definite transition for patients and a shift in the way they perceive their illness. This is just one potential explanation and further research is required to explore the mechanisms behind any change in quality of life due to treatment type.

Whilst this review highlights the importance of wound status, the influence of treatment alone indicates a more complex psychological mechanism than a direct link between healing and patients’ well-being. The effect of treatment on QOL may be mediated by multiple factors and future research would benefit from the development of a model of treatment effect on Quality of Life; quantifying the contribution of healing, treatment type, and other mediating factors. Future research might also look at the effect of recurrence rates on QOL, as it has been suggested that recurrence is the factor that differentiates superficial venous surgery from other treatment modalities. It is possible that the lower recurrence rates in surgical treatment and the psychological process of recovery from surgery²⁷ may improve QOL above other treatment types, as they remove the expectation of the leg ulcer returning and transforming the illness from chronic to acute. This expectation of recurrence is compared by some authors to being in remission from cancer and remaining vigilant for its return.²⁸ This relief from the expectation of leg ulcer recurrence, however, may only be applicable if the patient is informed of the lower recurrence rates associated with superficial venous surgery and if this is incorporated into their health beliefs.

Limitations

Whilst every effort was made to identify all relevant articles, through design of the search strategy and further hand-searching of relevant articles’ reference lists, the potential for missed articles remains and this may have influenced the conclusions of this review. Publication bias is not anticipated to have affected the results, as many studies reported non-significant results regarding quality of life outcomes; this may be because quality of life was often not a primary outcome measure in these articles. Although only English language studies were included in the review, no studies were excluded on the basis of language, so this is not expected to have influenced the results.

It must be considered that the average age of this population implies that a number of comorbidities may be present in participants. This adds complications for researchers in determining the effect of ulceration on QOL from the effect of other comorbidities and should be considered when interpreting results. However, this also emphasises the importance of utilising disease-specific measures in this population when measuring QOL and this should be considered when designing future research. Equally, research is often conducted with ‘hard to heal’ ulcer populations, as indicated in this review by the average ulcer duration of 13 months and average ulcer size of 10 cm across the included papers. This may be due to availability of sample population, suitability for treatment methods or increased motivation to participate in research. Those with ‘hard to heal’ ulcers are likely to suffer a considerably larger impact on their QOL and this factor should be considered when considering the clinical implications of this review and other research in this area.

It is believed that a meta-analysis would have added to the strength of this review; however, this was not considered possible by the authors due to the heterogeneity of the included articles and the absence of detailed data available. Articles differed greatly in the type of surgery, type of compression device, measures and time points investigated, and this heterogeneity led to the inclusion of articles investigating either conservative or surgical treatment, due to the scarcity of articles directly comparing the two methods. Studies also displayed variability in choice of control group and the value of the control groups used is a point of debate, with some problems identifying a suitable control group in this area of research. Research could utilise a placebo control in line with traditional RCT design; however, use of placebo controls have been ruled broadly unethical by the World Medical Association²⁹ and RCTs are now generally designed using treatment as usual or best available treatment as a control. Future research would benefit from careful consideration of control group design and increased homogeneity in study design and outcome measures. This would facilitate future meta-analyses and synthesis of data.

Conclusion

This systematic review aimed to evaluate the comparative impact of bandaging/compression treatments and superficial venous surgery on the Quality of Life of venous leg ulcer patients. The results suggest that all treatment improves patients’ quality of life to some extent, regardless of the treatment type. Wound status plays an important role in the extent of improvement, with greater ulcer healing leading to significantly improved quality of life outcomes. Type of bandaging did not appear to influence quality of life outcomes; however, studies investigating surgical treatment appeared to demonstrate improved quality of life compared to compression bandaging alone. The results of this review provide a synthesis of the literature and suggest possible directions for future research.

Footnotes

Conflict of interest

MW is founder of The Whiteley Clinic and The Leg Ulcer Charity.

Funding

This research was funded by ‘The Leg Ulcer Charity’ (Registered Charity – 1152113). Philippa Tollow is supported by a PhD Studentship funded by ‘The Leg Ulcer Charity’ – Registered with the UK Charities Commission, Registration number: 1152113.

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