A leg ulcer is an open wound between the knee and malleolus joint that is unhealed for at least 4 weeks (Scottish Intercollegiate Guidelines Network, 2010). They are painful and distressing, affect patients' quality of life and place a financial burden on healthcare providers (Gohel et al, 2007; Cwajda-Białasik et al, 2012). In recent years, several studies have evaluated leg ulcer management in the community (Guest et al, 2015; 2017a). However, little is known about the leg ulcer population in the acute hospital setting (Dealey, 1999; Aldeen, 2007; Anderson, 2017).
Patients admitted to hospital with active leg ulceration may be referred to multiple specialties such as plastic surgery, tissue viability (TV), vascular surgery, dermatology, infectious diseases and diabetic foot teams. This variety in specialty teams can lead to inconsistent management, affecting length of stay, investigations ordered and interventions carried out. Moreover, Guest et al (2015; 2017a) showed that nearly one in five people with a leg ulcer seen by the NHS received no differential diagnosis. A failure to determine the underlying cause of a wound implies that treatment has not been targeted correctly (Staines, 2018).
Although accurate data for leg ulcer prevalence are difficult to obtain (Anderson, 2017), a local wound care prevalence audit in July 2007 conducted by the authors' TV service in the same Trust showed that 2.6% (18 out of 702) of inpatients had active leg ulcers (unreported data). Dealey (1999) reported a similar prevalence of 1.8% (17 out of 931) in an acute trust. On 4 January 2018, a point prevalence audit by the same local hospital demonstrated a prevalence of 10.2% (75 out of 733 patients aged >55 years) (Lewis et al, 2018), highlighting the increasing burden of this disease. These observations are supported by the fact that the number of leg ulcer referrals to the TV service has increased dramatically since 2012 (Figure 1). Significantly, this figure does not include patients with leg ulcers who have been referred to other specialties or those who have not been referred at all. Unsurprisingly, these data reflect the national picture that the prevalence of leg ulcers is increasing and it is estimated that 1.5% of the UK population have a leg ulcer (Guest et al, 2015; 2017b).
This study aimed to note the number of leg ulcer referrals made to the TV service over two separate 3-month periods and compare the demographic data with the published data on leg ulcer population in both the acute and community settings.
Methods
A joint leg ulcer service project was undertaken by the TV and vascular surgery units for 3 months (December 2018–February 2019) with the aim of streamlining the service for patients with longstanding health conditions in group 2 of the study, as per the principles of the National Wound Care Strategy (2019), the NHSi Quality Improvement Strategy (Ham et al, 2016), the Cambridge University Hospital NHS Foundation Trust's strategy (2019) and NHS Outcome Framework Domain 2 (NHS Digital, 2019). In addition, a 3-month retrospective study (December 2017–February 2018) was carried out to provide a comparison cohort (group 1). The cohorts were combined to determine the demographics of the local leg ulcer inpatient population. This is referred to below and in Table 1 as the local study.
| Median age (interquartile range) (years) | Mean (SD) (years) | Prevalence | Number of leg ulcers | |
|---|---|---|---|---|
| Local study (2019) | 83.0 |
Not reported | 10.2% | 75 |
| Dealey (1999) | Not reported | Not reported | 1.8% | Not reported |
| Srinivasaiah et al (2007) | Not reported | Not reported | Not reported | 532 patients in community and acute settings |
| Vowden and Vowden (2009) | Not reported | Community and acute setting demographic data were combined (range: 63.9–79.9 years) |
Not reported | Not reported |
A standardised data collection proforma was produced to collect patient age, comorbidities and mortality rate, which was also assessed.
Search strategy
A literature search was undertaken to identify published papers reporting details of leg ulcer populations in acute settings using the following databases: Medline; Embase; British Nursing Index; and CINAHL. A structured search was undertaken in each database using the following key words in combination: ‘leg ulcer*’ ‘wound*’ ‘lesion*’ ‘lower limb*’ ‘leg*’ ‘acute hospital*’ ‘setting*’ and ‘trust*’. Truncation was used to expand the scope of literature search. Boolean logic was used to put key words alongside their synonyms. The inclusion criteria were studies in humans and original papers discussing leg ulceration in the acute setting. The exclusion criteria were foot ulcer and community setting. Studies were limited to those in English. Subject headings and snowballing techniques were also used to expand the search.
Results
A total of 130 patients were studied in the local population: 56 patients between December 2017 and February 2018 in group 1; and 74 between December 2018 and February 2019 in group 2.
In the literature review, 35 papers were retrieved. The PRISMA flow diagram (Moher et al, 2009) (Figure 2) was used to determine the eligibility of studies based on the systematic literature searches. Of these, 15 were duplicates and were removed and seven were community related. The 13 remaining papers were reviewed for relevance and 10 were excluded. This review discusses three papers reporting leg ulcer inpatient population in the acute settings are discussed: Dealey (1999), Vowden and Vowden (2000) and Srinivasaiah et al (2007).
Age
The local population data was compared with that in the literature from acute and community settings.
Local population
The median age for group 1 was 83.0 (interquartile range 74.25–88) and that for group 2 was 82.5 (interquartile range 72-89).
Acute settings
No studies reported patients' ages in the acute setting, although Vowden and Vowden (2009) reported a mean age of 63.9-79.9 years depending on ulcer aetiology in both acute and community settings (Table 1).
Community settings
There was a wide variation in patient ages in leg ulcer studies conducted in the community, with means ranging from 44.9 to 76 years and with the majority of patients aged over 70 years (Iglesias et al, 2004; Gohel et al, 2007; Dumville et al, 2009; Watson et al, 2011; Ashby et al, 2014; Eroglu and Yasim, 2018) (Table 2).
| Median age (interquartile range) (years) | Mean (SD) (years) | |
|---|---|---|
| Local study (2019) | 83.0 | Not reported |
| ESCHAR study (Effect of Surgery and Compression on Healing and Recurrence) Gohel et al (2007) | 72 (60–79) for compression group alone versus 74 (60–80) for compression plus surgery group | Not reported |
| EVRA study (Early Venous Reflux Ablation) Gohel et al (2018) | Not reported | 67.0±15.5 for early intervention group versus 68.9 ± 14.0 for deferred intervention group |
| VenUS I study Iglesias et al (2004) | Not reported | 71.9 (range 25–97) for four-layer compression bandage group versus 71.3 (range 23–96) for short-stretch bandage group |
| VenUS II Dumville et al (2009) | 76.0 (20.9–94.9) | 74.0 (SD 12.6) |
| VenUS III Watson et al (2011) | 71.85 | Not reported |
| VenUS IV Ashby et al (2014) | Not reported | 68.6 (SD 14.5) |
| Eroglu and Yasim (2018) | Not reported | 47.7±11.9 for N-butyl cyanoacrylate (NBCA) group versus 44.9±10.5 for radiofrequency ablation (RFA) group and versus 45.9±10.4 for endovenous laser ablation (EVLA) group |
Comorbidities
Local population
The local study found that inpatients with leg ulcers had multiple comorbidities, most commonly cardiac disease (present in 61.8%) followed by diabetes (28.9%) and respiratory disease (20.5%). Deep vein thrombosis was reported in 4.8% of patients (Table 3).
| Group 1 (n=56) | Group 2 (n=74) | Overall (n=130) | |
|---|---|---|---|
| Cardiac | 17 (70.9%) | 39 (52.7%) | 56 (61.8%) |
| Respiratory | 4 (16.7%) | 18 (24.3%) | 22 (20.5%) |
| Cerebrovascular event | 7 (29.2%) | 6 (8.1%) | 13 (18.65%) |
| Diabetes mellitus | 9 (37.5%) | 15 (20.3%) | 24 (28.9%) |
| Dementia | 6 (25.0%) | 10 (13.5%) | 16 (19.25%) |
| Obesity | 1 (4.2%) | 8 (10.8%) | 9 (7.5%) |
| Dermatology | 1 (4.2%) | 7 (9.5%) | 8 (6.85%) |
| Deep vein thrombosis | 1 (4.2%) | 4 (5.4%) | 5 (4.8%) |
| Autoimmune disorder | 1 (4.2%) | 10 (13.5%) | 11 (8.85%) |
| Chronic kidney disease | 3 (12.5%) | 14 (18.9%) | 17 (15.7%) |
Acute settings
No published studies reported patient comorbidities purely in acute settings. Two studies reported details of comorbidities in both acute and community settings, with Srinivasaiah et al (2007) identifying that 18.3% of patients with a leg or foot ulcer had diabetes and Vowden and Vowden (2009) reporting that people with neuropathic ulcers commonly had diabetes (90.8%) and neurological disorders (67.9%). Vowden and Vowden (2009) also reported that diabetes was common among people with arterial ulcers (40.4%) in both acute and community settings.
Community settings
The Effect of Surgery and Compression on Healing and Recurrence (ESCHAR) study (Gohel et al, 2007) reported that diabetes was present in 10% of patients with leg ulcers receiving compression therapy alone and 5% in the group treated with compression therapy plus surgery. The Early Venous Reflux Ablation (EVRA) study (Gohel et al, 2018) reported diabetes being prevalent in 15.2% in the early intervention group and 12.4% in the deferred intervention group. The Venous leg Ulcer Study IV (VenUS IV) reported that 17.2% of participants had diabetes (Ashby et al, 2014).
Deep vein thrombosis was also reported in the ESCHAR study (Gohel et al, 2007); it was found in 10% of patients receiving compression alone and 8% in those in the compression plus surgery group. The EVRA study (Gohel et al, 2018) reported a history of deep vein thrombosis in 6.7% of patients in the early intervention group and 6.6% in the deferred intervention group.
Mortality rate
Local population
Two cohorts of patients with leg ulcers in the local population were selected for analysis (the study and the comparison groups). The cohorts had different follow-up periods and so the mortality rate was analysed for each separately: in the comparison cohort (group 1), overall mortality was 52% at one year and, in the study cohort (group 2), mortality was 20% at 3 months.
Acute settings
Mortality rates were not reported in any of the studies conducted in acute settings.
Community settings
The ESCHAR study (Gohel et al, 2007) reported the overall mortality rate as 17% at 3 years, whereas the VenUS IV (Ashby et al, 2014) study demonstrated an overall 489 deaths out of 3949 participants over a 30-month period of quarterly follow-up surveys, which corresponded to a quarterly rate of death of 3.7%.
Discussion
This study showed that inpatients with leg ulceration are around 10 years older than people with ulceration in the community. Patients in acute care settings also have higher levels of coexisting medical conditions and considerably higher mortality. Around half the patients in this study had died within 12 months, indicating that the priorities for leg ulcer care may be very different for this group in comparison with outpatients.
Few published studies report the age of inpatients with leg ulcers. However, it is apparent that those in the local study were approximately 10 years older than any of the cohorts in the published literature, which is significant. The higher age in this cohort and the fact that these patients were admitted to hospital could partly explain the increased number of comorbidities and high mortality rate.
Although detailed comorbidities were not reported in most published studies, diabetes was commonly recorded and appeared to be significantly higher in the local study than in the ESCHAR, EVRA and VenUS IV studies. Not surprisingly, diabetes was highest among people with arterial ulcers in both the acute and community settings (Vowden and Vowden, 2009). The ESCHAR study (Gohel et al, 2007) reported the highest percentage of deep vein thrombosis while the percentage in the local study was similar that in the EVRA study (Gohel et al, 2018). The findings from the local study showed that inpatients with leg ulcers in acute settings have significant comorbidities. It is well established that underlying comorbidities such as cardiac history and diabetes increase the risk of developing leg ulceration (Agale, 2013).
It is also likely that the much higher age in the local study cohort explains the high number of comorbidities in these patients.
Reported mortality rate in the ESCHAR study was 17% at three years and, in the VenUS IV trial, a quarterly rate of death of 3.7% was observed. Nevertheless, the local study has demonstrated that mortality rates are significantly higher for patients with leg ulcers in the acute setting than for those in community settings.
Implications for practice
The leg ulcer population in acute settings has a very different demographic picture from that in primary care or community settings. Whereas aggressive assessment of arterial and venous systems is widely advocated and supported by literature and guidelines for community leg ulcer patients, this approach may not be suitable for many inpatients with leg ulceration, as was evident in the study reported here. The fact that more than half of patients had died within 1 year clearly indicates that the treatment priority may be symptom control or palliation for many patients.
Of course, interventions to address underlying arterial or venous disease may still be appropriate, but management decisions should be made on a case-by-case basis, in collaboration with the patient, family and medical teams. Simple, minimally invasive measures such as prompt ankle-brachial pressure index evaluation, elevation where appropriate and compression therapy are still the mainstay of management for the majority of inpatients, as observed in this study.
Limitations
This local study focused only on inpatients with leg ulceration who had been referred to tissue viability services, and automatically excluded patients referred to other specialities and those who were not referred at all. In addition, comparing findings about the local population to those in published literature relied on the reporting in those studies, and a paucity of data was available on comorbidities for comparison.
Conclusion
Systematic, accurate understanding of the demographics of inpatients affected by leg ulcers will help target NHS resources appropriately by reducing unnecessary investigations and enabling referral and care pathways that are evidence based and patient centred.
Further research is required to understand the aetiology and outcomes of leg ulcers for the inpatient population. This will help inform the development of a referral pathway as well as the implementation of an evidence-based patient care pathway with the aim of ensuring that patients get the most appropriate care in their acute hospital journey.