Audit of co-morbidity patterns and 5-year survival among patients presenting to a rapid access leg ulcer service

Abstract

Background: While leg ulceration is common, data regarding long-term is limited. Historical data indicate that approximately 50% of leg ulcer patients die within 5 years of presentation. However, little is known regarding survival outcomes in contemporary patient populations. This retrospective study aimed to assess 5-year survival in patients attending a vascular leg ulcer clinic. Objectives: To evaluate 5-year survival among patients with leg ulcers and to analyse the effect of ulcer aetiology and patient co-morbidities on survival. Methods: Over 30 months (2016 to 2018), 119 new patients were assessed at the leg ulcer clinic and followed over 5 years. Baseline co-morbidities, ulcer type, interventions performed, and 5-year survival were recorded. Survival was calculated using Kaplan-Meier curves. Co-morbid burden and survival were compared between venous and arterial/mixed patients. Results: Overall 5-year survival was 74%. Venous patients fared better than arterial/mixed patients (5-year mortality 16/88 vs 15/31; p < .01 log-rank test). Arterial/mixed patients had a greater burden of co-morbidities. In multivariate regression modelling, the presence of three or more co-morbidities at presentation was the only significant predictor of mortality. Conclusions: Overall, 5-year survival for leg ulcer patients has improved compared to historical data but remains static for arterial/mixed patients.

Keywords

Vascular leg ulcer leg ulcer healing rates survival rates of leg ulcer patients co-morbidities and leg ulcer healing leg ulcers predictors of healing

Introduction

Leg ulcers affect 1 to 2% of the population, the prevalence increasing with age.^1,2 Most are venous³ and are considered chronic if there is no tendency to heal after 3 months or if full healing has not occurred within 12 months.⁴ Normal wound healing may be impaired by multiple factors, both modifiable (e.g., smoking, obesity, malnutrition, diabetes, venous hypertension, cardiovascular disease) and non-modifiable (e.g., ageing).⁵ Leg ulcers become more common with age as do co-morbidities such as diabetes that impair wound healing. Therefore, as the population ages, the burden of chronic ulceration is likely to increase. A large recent cohort of 1000 leg ulcer patients reflected both the advancing age of these patients (mean age 69 years) and the co-morbid burden. Venous ulcer patients frequently were also hypertensive (65%), obese (49% or diabetic (20%). Survival was not evaluated.⁶

Management guidelines for patients with lower limb arterial ulceration contain specific detailed recommendations regarding co-morbidity management.⁷ Conversely, guidance regarding co-morbidity management in venous ulcer patients is generally limited to generic advice to consider optimisation of co-morbidities to aid healing or involvement of a family physician for co-morbidity management, without specific recommendations for specific co-morbidities.^8,9 Early interventions such as local anaesthetic venous ablation may improve ulcer healing outcomes.¹⁰ However, the impressive healing rates (86%) obtained in a large trial with highly selected patients¹⁰ are more difficult to achieve in less selected cohorts,¹¹ possibly reflecting the influence of patient co-morbidities. Available data regarding 5-year survival among patients presenting with leg ulceration suggest survival rates of 50 to 60%^12,13 although some of these series are almost 30 years old. We aimed to evaluate co-morbidities and contemporary survival among unselected patients presenting to a rapid-access leg ulcer service as such data are currently sparse and should be considered when establishing rapid-access services.

Objectives

Primary objective

This study aimed to determine the survival rates of patients with leg ulcers who visited the rapid-access leg ulcer clinic.

Secondary objectives

Calculate the co-morbidity burden on this cohort and healing rates of ulcers based on aetiology.

Methods

In July 2016, a one-stop leg ulcer clinic was introduced. Patients can be referred to the rapid access clinic from general practice, community wound care services, and general surgical teams in affiliated hospitals. There is a separate pathway for patients with diabetic foot ulceration. After their initial assessment, and intervention if performed, patients are reviewed every 4 weeks until ulcer healing. If this is impractical, e.g., travel difficulties, patients are followed up in the community by the specialist clinic nurses.⁷

The clinic is run by a vascular clinical nurse specialist and a vascular surgeon who assess patients for venous disease and determine their suitability for endovenous intervention. Point-of-care venous duplex and ankle-brachial index measurements are available. The aim is to provide same-day treatment of superficial venous reflux and compression therapy as appropriate. The decision on which procedure to perform (axial thermal or mechanochemical ablation, sub ulcer venous plexus ultrasound-guided foam sclerotherapy) is made in consultation with the patient. Compression bandaging is offered to all patients with a venous leg ulcer and superficial or deep venous reflux, provided their ankle-brachial index is greater than 0.5.

The clinic maintains a database of presenting patients for audit and quality assurance purposes. Basic demographics, ulcer type (venous, arterial, mixed, other), age, gender, intervention performed, and healing are recorded. For the purposes of this project, supplemental data regarding co-morbidities unplanned hospital admissions and death were obtained from the hospital’s electronic patient record and administrative databases. The co-morbidities were selected based on those used in previous series (diabetes, ischaemic heart disease, peripheral arterial disease, elevated body mass index, heart failure, inflammatory joint disease, venous thromboembolism).^6,12,13 Data regarding cognitive impairment, cerebrovascular disease and chronic respiratory disease were also recorded as common co-morbidities which may plausibly impact 5-year survival. To maximize data capture, data regarding co-morbidities were based upon the patients’ history, cross-checked with pre-existing records from other departments and communications from the patients’ general practitioner. The primary aim was to evaluate co-morbidity rates and 5-year survival for comparison to previous international survival data. As such, the project was considered an audit using retrospective data which did require explicit ethical approval.

Patients presenting to the one-stop clinic between July 2016 and December 2018 were included in this analysis. For survival analysis, patients were censored at 5 years from their first presentation or death. Survival was calculated as per Kaplan-Meier. Cox regression modelling was used to determine whether there was a relationship between co-morbid burden and death during follow-up. Variables with a p-value of 0.1 or less in univariate Cox regression were included in a multivariate Cox regression to test for an independent relationship with survival. In the multivariate model, p<.05 was considered significant. Continuous variables were compared using the Mann-Whitney U-test. Categorical variables were tested using the chi-square test. The statistical analysis was performed using StatsDirect 2.8.0 (Statsdirect Ltd, United Kingdom).

Results

The service assessed 119 new patients between July 2016 and December 2018. Cohort characteristics are shown in Table 1. As expected, the cohort was largely older (mean age, 72 years), and the majority of ulcers were venous (75%). The most frequent intervention was superficial venous reflux ablation (47%), followed by compression alone (26%) (Table 2). Healing occurred in 74 patients during the follow-up period (62%). Just over one-quarter (26%) of the cohort died during follow-up (Figure 1), with a mean survival of 4.5 years (95% confidence interval (4.34 to 4.77 years). Atrial fibrillation was the most frequent co-morbidity (Table 3). Across the cohort, the median number of co-morbidities per patient was one (interquartile range, 0–2) (Figure 2). Sixteen patients had 3 or more co-morbidities. Patients with venous ulceration tended to have fewer co-morbid conditions (median, 1; interquartile range, 0–2) than arterial/mixed patients (median, 2; interquartile range, 1-3) (p < .0001). Venous patients were less likely to have >3 co-morbidities (venous 4/88, artery/mixed 12/31; p < .001).

Table 1.

Cohort characteristics.

Age	72 years ± 13.4
Female	57 (48%)
Venous	89 (75%)
Arterial	20 (17%)
Mixed	10 (8%)

Table 2.

Ulcer treatment modalities.

Superficial venous reflux ablation	56 (47%)
Compression alone	31 (26%)
Arterial revascularisation	13 (11%)
Local ulcer care only	13 (11%)
Deep venous stenting	5 (4%)
No intervention	1 (1%)

Figure 1.

Five-year survival.

Table 3.

Co-morbidities.

	Death within 5 years (n = 31)	Alive at 5 years (n = 88)	Univariate p
Atrial fibrillation	8 (26%)	9 (10%)	0.1
Valvular heart disease	2 (6%)	2 (2%)	0.46
Ischaemic heart disease	5 (16%)	11 (13%)	0.52
Heart failure	5 (16%)	2 (2%)	0.02
Cerebrovascular disease	2 (6%)	6 (7%)	0.98
Peripheral arterial disease	4 (7%)	7 (8%)	0.31
Chronic inflammatory joint disease	1 (3%)	8 (9%)	0.32
Cognitive impairment	1 (3%)	1 (1%)	0.45
Venous thromboembolism history	6 (19%)	8 (9%)	0.14
Diabetes	7 (23%)	15 (17%)	0.38
Renal impairment	2 (6%)	3 (3%)	0.41
Active malignancy	2 (6%)	0	0.02
Body mass index >40	3 (10%)	6 (7%)	0.001
Chronic respiratory disease	3 (10%)	7 (8%)	0.001
Venous ulcer	16 (52%)	70 (80%)	0.02
Arterial ulcer	8 (26%)	12 (14%)	0.21
Mixed ulcer	7 (23%)	3 (3%)	0.007
Total co-morbidities (median, interquartile range)	1 (0 to 3)	1 (0 to 2)	0.17
>3 co-morbidities	9 (29%)	7 (8%)	0.003

Figure 2.

Co-morbid burden for the cohort.

In univariate Cox regression models, atrial fibrillation, heart failure, active malignancy, body mass index >40, chronic respiratory disease, venous ulceration, mixed ulceration, and total co-morbidities of >3 potentially influenced survival (Table 3). In multivariate Cox regression modelling including any variable with a univariate p-value of 0.1 or less, only total co-morbidities >3 retained an independent relationship with survival. Half of the deaths within 5 years occurred in patients with venous ulceration, but overall, venous patients had significantly greater survival (venous relative rate 0.72, arterial /mixed relative rate 1.69, p = .01; log-rank test) (Figure 3).

Figure 3.

Survival curves for patients with venous (o) compared to arterial mixed ulcers ( ).

Discussion

Studies of chronic leg ulceration patients tend to focus on ulcer healing with less consideration for long-term survival. A previous analysis of almost 400 leg ulcer patients reported an overall 5-year survival of 52%,¹² significantly lower than a comparable control population (68%). Higher mortality was also observed among our leg ulcer patients (52 per 1000 per year) compared to the average national mortality for adults over 65 years (36.8 per 1000 per year).¹³ A more recent population-based study from Denmark considered survival in patients receiving specialist treatment for leg ulceration between 2007 and 2012.¹⁴ 39% died within 5 years, worse than our observed 5-year mortality of 26%. Venous ulceration was not specifically analysed but peripheral arterial disease was associated with reduced 5-year survival as was co-morbidity burden. A smaller study of 70 elderly leg ulcer patients reported 39% died within 4 years of initial assessment¹⁵ while 20% of leg ulcer patients in Sweden died within 18 months.¹⁶

The majority of patients in the one-stop clinic have venous ulceration. Nelzen et al previously noted that venous ulcer patients had better 5-year survival (63%) than patients with arterial/other ulcers (40%).¹² That finding persists in our more recent data which demonstrate that the 5-year survival for venous patients (82%) is better than arterial/mixed patients (52%). This probably relates to the higher co-morbidity burden observed in arterial /mixed patients.

The observed co-morbid burden in the arterial/mixed patients presenting to a rapid access leg ulcer clinic may provide an opportunity for greater medical optimisation. Current guidelines for arterial ulcer patients include recommendations regarding secondary prevention measures, including specific targets for blood pressure and glycosylated haemoglobin.⁷ Qualitative data suggest vascular surgeons perceive numerous obstacles to engaging in medical risk-factor management,¹⁷ which may partly relate to training focussed largely on technical procedural interventions.¹⁸ Surgeon-internal medicine co-management of vascular inpatients may improve mortality in this high-risk group.¹⁹ A similar approach adopted in the outpatient setting could improve survival outcomes. While it may be logistically and organizationally challenging, the observed 5-year mortality in this patient group is considerably worse than many common cancers²⁰ and merits reduction efforts.

Conclusion

While relatively small, this series demonstrates that overall, 5-year survival among patients presenting to a vascular one-stop leg ulcer service has improved somewhat in recent years. Those with arterial/mixed ulceration continue to fare poorly. Surgeon-internal medicine outpatient co-management may yield improvement for this high-risk group.

Limitations

Limitations of this study include its single-center design, which may limit generalizability. However, the vascular leg ulcer clinic in this study functions as a rapid-access service, ensuring that the cohort represents a broad cross-section of patients with leg ulcers. Additionally, while we accounted for several co-morbidities, other factors that might impact survival, such as socioeconomic status or access to care, were not included in our analysis. Future studies should aim to explore these factors to provide a more comprehensive understanding of survival in this population.

This study discusses the documented co-morbidities. In cases where patients had undiagnosed or undocumented co-morbidities or were diagnosed after the study period, we did not have access to this information. Ulcer assessment was based on the presence or absence of ulcers. Factors such as recurrent, worsening, or healing ulcers were not considered.

Footnotes

Acknowledgements

This study was entirely self-funded, and we did not receive financial support from any institutions. We declare no conflicts of interest. We extend our gratitude to the reviewers for their time and effort in providing constructive feedback. We want to thank Professor Walsh for his help and guidance throughout the stages of the research and manuscript writing.

Authors’ contributions

The study was conducted at Roscommon University Hospital, where the rapid access leg ulcer clinic is located. Additional data were collected from Galway University Hospital by members of the same vascular team. Both hospitals are within the same catchment area. Ahmmad Alfatih Ahmmad (Corresponding Author): Conception and design of the study, drafting of the article, Data collection, both centres; Tayyaub Mansoor: Data collection-Roscommon University Hospital. Doireann Joyce: data collection-Galway University Hospital; Daniel Westby: Data collection, Galway University Hospital. Marie O`Shaughnessy: data collection Roscommon University Hospital; Stewart Walsh: supervisor. Final approval of submitted version, data analysis. The study was conducted in two different centres by the same team. The vascular unit is at Galway University Hospital in Galway, while the rapid access leg ulcer clinic is at Roscommon University Hospital in Roscommon, Co. Roscommon. Some of the data were collected from Roscommon and the rest from Galway. Both hospitals are within the same catchment area.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Declaration of research ethics

According to the institution’s guidelines, audits and quality improvement projects are exempted from ethical approval. So, we did not pursue it.

Guarantor

Professor Stewart Walsh.

Ethical statement

ORCID iDs

Ahmmad Alfatih Ahmmad

Doireann Joyce

Daniel Westby

Colum Keohane

References

Hodde

Allam

. Small intestinal submucosa wound matrix for chronic wound healing. Wounds 2007; 19: 157–162.

Clarke-Moloney

Keane

Kavanagh

. An exploration of current leg ulcer management practices in an Irish community setting. J Wound Care 2006; 15: 407–410.

Fife

Walker

Thomson

, et al. Limitations of daily living activities in patients with venous stasis ulcers undergoing compression bandaging: problems with the concept of self-bandaging. Wounds 2007; 19: 255–257.

Kahle

Hermanns

Gallenkemper

. Evidence-based treatment of chronic leg ulcers. Dtsch Arztebl Int 2011; 108: 231–237.

Avishai

Yeghiazaryan

Golubnitschaja

. Impaired wound healing: facts and hypotheses for multi-professional considerations in predictive, preventive and personalised medicine. EPMA J 2017; 8: 23–33.

Jockenhöfer

Gollnick

Herberger

, et al. Aetiology, comorbidities and cofactors of chronic leg ulcers: retrospective evaluation of 1 000 patients from 10 specialised dermatological wound care centers in Germany. Int Wound J 2016; 13: 821–828.

Conte

Bradbury

Kolh

, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg 2019; 69: 3S.e40–125S.e40.

De Maeseneer

Kakkos

Aherne

, et al. Editor’s choice - European society for vascular surgery (ESVS) 2022 clinical practice guidelines on the management of chronic venous disease of the lower limbs. Eur J Vasc Endovasc Surg 2022; 63: 184–267.

Evans

Kuhnke

Burrows

, et al. Best practice recommendations for the prevention and management of venous leg ulcers. Wounds Canada. 2019. Available from: https://www.woundscanada.ca/docman/public/health-care-professional/bpr-workshop/1521-wc-bpr-prevention-and-management-of-venous-leg-ulcers-1874e-final/file

10.

Gohel

Mora MSc

Szigeti

, et al. Long-term clinical and cost-effectiveness of early endovenous ablation in venous ulceration: a randomized clinical trial. JAMA Surg 2020; 155: 1113–1121.

11.

Keohane

Westby

Twyford

, et al. Axial ablation versus terminal interruption of the reflux source (aavtirs): a randomised controlled trial. Vasc Endovasc Surg 2024; 58: 805–812.

12.

Nelzen

Bergqvist

Lindhagen

. Long-term prognosis for patients with chronic leg ulcers: a prospective cohort study. Eur J Vasc Endovasc Surg 1997; 13: 500–508.

13.

Central Statistics Office . Vital statistics yearly summary 2022. Central Statistics Office, 2023. https://www.cso.ie/en/releasesandpublications/ep/p-vsys/vitalstatisticsyearlysummary2022/.

14.

Madsen

Hyldig

Juel

. Outcomes in patients with chronic leg wounds in Denmark: a nationwide register‐based cohort study. Int Wound J 2022; 19: 156–168.

15.

Wissing

Unosson

. A follow-up study of ulcer healing, nutrition, and life-situation in elderly patients with leg ulcers. J Nutr Health Aging 2001; 5: 37–42.

16.

Ebbeskog

Skonda

Lindholm

, et al. A follow-up study of leg ulcer patients in south Stockholm. J Wound Care 1999; 8: 170–174.

17.

Pong

Yap

CJQ

, et al. Understanding the use of evidence-based medical therapy in patients with peripheral artery disease: a qualitative study using the tailored implementation for chronic diseases framework. Ann Acad Med Singapore 2023; 52: 651–659.

18.

Walsh

Kwan

. Vascular surgeons and best medical therapy: missed opportunities. Ann Acad Med Singapore 2023; 52: 645–646.

19.

Foley

Westby

Walsh

. Systematic review and meta-analysis of the impact of surgeon-physician Co-management models on short term outcomes for vascular surgery inpatients. Eur J Vasc Endovasc Surg 2024; 68: 336. DOI: 10.1016/j.ejvs.2024.05.005.

20.

Armstrong

Swerdlow

Armstrong

, et al. Five-year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res 2020; 13: 16.