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Introduction

Chronic venous disease is caused by abnormalities of the venous wall and valves or venous thrombosis leading to reflux, obstruction, or both. Ulceration is a severe manifestation of the disease¹ with a prevalence of 0.05% to 1% of the population,² which doubles after the age of 65 years.³ Recurrence rates are reported from 33%⁴ to almost 70% over 12 months.⁵ Barwell et al⁶ and Milik et al⁷ reported rates of less than 30% from randomised controlled trials which had strict follow up and compression therapy protocols.

Venous ulcers can linger for months or years³ driving up the cost of treatment. The estimated direct cost annually for managing patients with venous leg ulcers in the UK was reported to be over £2 billion⁸ and in Australia treatment of chronic wounds found to cost more than $3 billion per year.⁹ An Australian study calculated the cost for patients receiving guideline-based prevention and treatment to be AUD $294.72 per week which was significantly higher than for patients receiving standard care at $214.61 per week; however guideline-based care was associated with faster healing and increased quality of life.¹⁰ The physical and emotional toll can be immense with reports of pain, reduced social activity^11,12 and depression and anxiety.¹³

Preventing recurrence will reduce the burden of venous leg ulcers on society and is possible with surgery¹⁴ and surgery and compression combined.¹⁵ However, there is no strong evidence that surgery for deep venous disease can prevent recurrence.¹⁶ Long-term compression is effective, but not well tolerated¹⁷ due to pain, cost,¹⁸ discomfort, lack of understanding and motivation.¹⁹ Treatments to prevent recurrences are enhanced by lifestyle changes, such as leg elevation and exercise.^17,20

Numerous risk factors have been associated with recurrence, including low body mass index,^5,20 haemosiderosis, increased time sitting, use of antidepressants,²¹ male gender,²² deep venous thrombosis,^5,23 delayed healing of previous ulcer⁵ and history of previous ulcers.^5,24 Low levels of social support²¹ have also been found to increase the likelihood of recurrence while increased levels of self-efficacy reduce the possibility of recurrence.⁵

Unfortunately, identification of these risks of recurrence has not resulted in a reduced recurrence rate. It is likely that there are numerous competing factors making the management of venous disease complex. Further examination of the medical profile and health behaviours of patients with healed venous ulcers may uncover additional predictors of recurrence to assist clinicians and patients in recognising the risk of an impending recurrence. The aim of this prospective study was to identify factors associated with recurrent ulcers within 12 months post healing.

Methods

Study design

A prospective longitudinal study design was employed. Recurrence was defined in this study as a wound resulting from venous disease that occurs after healing of a previous venous ulcer and presented on the same lower leg.

Sample and setting

MedCalc for Windows Version 16.4.3 was used to calculate the sample size prior to recruitment. A sample of 114 participants, including 20% drop out, was identified as required using the parameters of 80% power, 95% confidence interval, and a significance level of 0.050. The calculation was based on an effect size of 0.3 reported in previous research.⁵ Participants were recruited from two metropolitan hospital community nursing clinics and services and a regional Leg Club and Leg Ulcer Clinic. Inclusion criteria included individuals whose leg ulcer had been healed for no longer than four weeks and was primarily of venous aetiology and an ankle brachial pressure index >0.8 and <1.3. The ulcer could either be their first venous leg ulcer, or a recurring ulcer. Patients were excluded from the study if they had a diagnosed cognitive impairment, were confined to a wheelchair or unable to mobilise or were unable to speak or comprehend English. See Table 1 for demographic details.

 

Table 1. Demographic information

 

Data collection and measures

Recruitment and data collection occurred between September 2015 and February 2018. Participants’ data were collected within four weeks of healing of their venous leg ulcer (at recruitment) and again at three, six, nine and 12-months post-healing. If they experienced a recurrence during that time, follow up was discontinued. Data were initially collected either at the treatment centre or the participant’s home via clinical assessment and a questionnaire comprised of 60 questions. Information was collected on demographics, medical history, current medications, venous leg ulcer history, history of wound infection or cellulitis, compression usage and care, skin care, exercise and daily activity, foot and ankle exercises, leg elevation, itch on the study leg, pain at the site of the healed ulcer, use of a protective dressing at the site of the healed ulcer and strategies for prevention of recurrence. A clinical assessment by the researcher gathered information on status of the skin and tissue on the lower leg. Ankle brachial pressure index (ABPI) was measured with a hand-held Doppler ultrasound or provided by the treating physician and range of ankle movement measured using a goniometer. Participants’ weight was recorded on digital scales and their height measured with a portable stadiometer. These recordings were converted to the participants’ BMI (body mass index). If there were any safety concerns this information was collected from the clinical notes or provided by the participant.

Participants were also given the Venous Leg Ulcer Self-efficacy Tool (VeLUSET)^25,26 following author permission. The tool has had construct validity, internal consistency reliability, and test re-test reliability established. The tool is comprised of 30 questions and five sections: general self-care tasks, daily self-care tasks, normal living, developing expertise and avoiding trauma. Participants were asked to score on a scale of 0 to 10 describing how confident they were in carrying out each of the activities on the questionnaire to prevent their leg ulcers from recurring. The higher the score the higher the level of self-efficacy.

Interviews for the subsequent timepoints were conducted by phone and the questionnaire comprised 40 questions. Information about changes in the participants’ health status, compression usage, and preventive strategies were collected. If a recurrence had occurred, the date and site of the recurrence were provided by the participant. Data were gathered on the participants’ beliefs about what may have initiated the recurrence and whether the wound had been infected. Participants were posted the VeLUSET^25,26 and the completed tool was returned by mail.

Data analysis

Data were analysed using IBM SPSS Statistics for Windows Version 23. Descriptive analysis was used to examine all variables and survival analysis employed for bivariate analysis (using Kaplan-Meier test) and multivariate analysis using a Cox proportional hazards regression model. Checks for multicollinearity were run using Pearson’s product correlation and Spearman rank order correlation and inspection of scatter plots prior to inclusion of the variables in the model. All variables in the bivariate analysis associated with recurrence with a p value <0.05 were included in the model for multivariate analysis.

Results

Sixty eligible adults were contacted and invited to participate in the research. The calculated sample size was unable to be invited due to a change to an acute care focus of one of the community nursing services, resulting in the absence of adults fitting inclusion criteria for recruitment from the service. Nine declined for no given reason and one died prior to giving informed consent. A sample of 50 participants 23 males (46%) and 27 females (54%) participated. Ages ranged between 53 and 96 years, mean age 77.18 years (SD 10.631). See Table 1 for participant demographic information.

Eleven participants were not followed up for the full 12 months as they were unable to be contacted and were censored for the survival analysis at time of dropout. All participants who reached the 12-month timepoint without experiencing a recurrence were also censored at 12 months. In survival analysis, time is measured for each participant either to the event (recurrence) or if the event does not occur at the end of the study. Therefore, they were censored either at the time of dropping out of the study or at completion of the study follow-up (12 months) when the event has not occurred. Participant flow from initial contact through data collection points is demonstrated in Figure 1.²⁷

 

Figure 1. Participant flow from initisal contact through data collection points

 

Fourteen (28%) of the 50 participants had experienced recurrence at three months post-healing. By 12 months, 27 of the 39 (69.2%) participants who reached that time point had experienced recurrence. Using survival analysis, mean time to recurrence was 33.15 weeks (95% CI 28.19–38.09). A range of clinical signs and symptoms, medical, psychosocial and preventive activity variables were examined for relationships with recurrence. See Table 2 for medical conditions, clinical signs and symptoms and preventive activities.

 

Table 2. Medical conditions, clinical signs and symptoms and protective activities

 

The presence of lower limb oedema at the time of healing was significantly related to increased likelihood of recurrence, with mean time to recurrence for participants with oedema 26.96 weeks (95% CI 20.75–33.18), compared to 41.84 weeks (95% CI 35.51–48.18) for those without oedema (p=0.006). There was a significant association between recurrence and itch in the study leg at the time of healing, with a mean time to recurrence of 25.28 (95% CI 17.49–33.06) weeks to recurrence for participants with itch, compared with 37.45 weeks (95% CI 31.61–43.29, p=0.021) for participants without itch. Participants with a history of multiple leg ulcers in the study leg had a mean time to recurrence of 28.28 weeks (95% CI 22.28–34.28), compared to a mean time to recurrence of 41.29 weeks (95% CI 34.08–48.51, p=0.015) in participants without a history of multiple ulcers. A comorbidity of hypothyroidism (found in seven (14%) participants) was significantly associated with a lower risk of recurrence. These participants had a mean time to recurrence of 46.43 weeks (95% CI 36.32–56.54), compared to 30.84 weeks (95% CI 25.63–36.05, p=0.036) for participants who did not have hypothyroidism.

Examination of medication usage found a significant relationship between recurrence and antibiotic usage. Three participants (6%) were taking antibiotics at the time of healing and had a mean time to recurrence of 17 weeks (95% CI 3.95–30.05), while participants not taking antibiotics had a mean time to recurrence of 34.27 weeks (95% CI 29.19–39.35, p=0.035). In addition, participants using topical steroids had a mean time to recurrence of 23 weeks (95% CI 12.92–33.08) compared with participants who were not using topical steroids, who had a mean time to recurrence of 35.28 weeks (95% CI 29.93–40.64, p=0.040).

Looking at preventive activities, few participants wore compression garments. No particpants wore class 3 compression hosiery; none wore Velcro compression wraps and two used pneumatic compression pumps five to seven days per week. Twelve (24%) participants wore class 2 compression hosiery (20–30 mmHg) for at least five days a week. This group were significantly less likely to recur, with mean time to recurrence for participants wearing class 2 compression hosiery (>five days a week) 43.33 weeks (95% CI 34.67–52.00) compared to 29.84 weeks for those who did not wear class 2 compression hosiery >five days a week (95% CI 24.37–35.32, p=0.027). Participants who had difficulty putting on their compression stockings had a higher venous ulcer recurrence compared to participants who did not have difficulty putting on their compression stockings (p=0.013, see Table 2). Similarly, participants who had problems taking off their compression stockings had a shorter mean time to recurrence, compared to those who did not have difficulty taking off their compression stockings (p=0.033, see Table 3).

 

Table 3. Relationships between compression usage and recurrence: Kaplan-Meier survival curve analysis

 

Of the 15 participants using compression stockings at six months post-healing, the four who had replaced them recently had not experienced a recurrence. Six of the 11 participants who had not replaced their stockings experienced a recurrence (p=0.071). Looking at self-efficacy, a higher mean daily self-care tasks VeLUSET^25,26 subscale score was found in participants who did not experience a recurrence, in comparison to those who did recur (p=0.032, see Table 4).

 

Table 4. Relationships between self-efficacy and recurrence: Independent-samples t-tests. N=32

 

Cox proportional hazards regression model

The assumptions for the regression model were checked.²⁸ Only three participants were taking antibiotics, therefore the antibiotic usage variable was excluded from the model. Difficulty removing compression stockings was also excluded as it was highly correlated with difficulty putting on compression stockings. The remaining variables significantly associated with recurrence at the bivariate level were entered into the model and included: hypothyroidism, oedema in the study leg, history of multiple venous leg ulcers on the study leg, wearing class 2 compression stockings for greater or equal to five days a week, difficulty with application of compression stockings, itch, application of topical steroids, and the VeLUSET^25,26 daily self-care tasks subscale score. All variables associated with recurrence (p<0.05) at the bivariate level were entered simultaneously into the Cox proportional hazards regression model. Backwards elimination was undertaken to remove non-significant variables which did not contribute to the strength of the model. Two variables were retained in the model which did not remain independently significantly associated with recurrence. However, they contributed to the overall strength of the model.

After adjustment for all variables, the model showed topical steroid usage, oedema in the study leg, and the VeLUSET^25,26 daily self-care tasks subscale score remained significantly associated with recurrence (p<0.001, see Table 5). Participants who had oedema in the study leg at time of healing were 9.8 times more likely to experience a recurrence than participants who did not have oedema (95% CI 1.38–69.28) and participants using topical steroids were 4.1 times more likely to experience a recurrence (95% CI 1.07–15.57) than participants who were not using topical steroids. A lack of confidence in accomplishing the daily self-care tasks listed on the VeLUSET^25,26 subscale increased the likelihood of a recurrence (95% CI 0.929-0.992).

 

Table 5. Cox proportional hazards regression model

 

Discussion

The incidence of recurrence in this study was high. At three months there were 14 recurrences (28%) of the sample and at 12 months there were 27 recurrences (69.2%) of the remaining 39 participants. While these numbers of recurrences are similar to some other studies,^{20, 21} a mixed methods study of 145 participants reported fewer recurrences at 12 months (33.1%), with inconsistant compression usage the only reported avoidance strategy.⁴

Levels of self-efficacy were examined in the current study using the Venous Leg Ulcer Self-efficacy Tool (VeLUSET).^25,26 Increased scores on the daily self-care task subscale were significantly related to a lower risk of recurrence which was retained in the final model. These results indicate the need for confidence in carrying out recommended self-care activities likely to prevent a recurrence, including compression garment usage. Increased levels of self-efficacy have been linked to a reduced risk of recurrence by Finlayson et al⁵ However, Probst et al⁴ found self-efficacy scores unchanged for participants who experienced a recurrence and those who did not and noted self-efficacy levels were surprisingly high. The discrepancies in results on self-efficacy in the literature may be due to the use of non-disease specific self-efficacy tools. In contrast, this study has used a newly developed venous leg ulcer specific tool. Results demonstrate the need for clinicians to provide support for adults in developing their skills and confidence in daily self-care tasks. Further research is needed with the VeLUSET^25,26 to confirm these new findings.

Topical steroid usage was a significant independent predictor of recurrence in the final multivariate model. Previous research has not identified this link. While this is a new finding, the low number of participants mean it must be taken with caution and further research is needed. Topical corticosteroids are frequently used to treat venous eczema,²⁹ which is an inflammatory cutaneous change in the leg in chronic venous disease.³⁰ Unfortunately, the eczema will remain or recur if the venous hypertension is not eliminated.³¹ In the current study, venous eczema was not significantly associated with recurrence which is not surprising given the steroid treatments which could have addressed the symptoms of the eczema. Itch on the study leg reached statistical significance at the bivariate level and was associated with a higher risk of recurrence. Of the 17 participants with itch, six were on topical steroids. The cause of the itch is unknown as participants were not asked to provide information on the issue. However, itch can signal the development of venous eczema and incite a scratch response,³² which could potentially break the skin and result in ulceration. Qualitative studies have reported itch as a trigger for recurrence,^33,34 however, subsequent quantitative studies have not provided additional evidence about the issue.

Despite the strong evidence suggesting compression therapy will reduce the risk of recurrence,¹⁷ compression usage was low in this study and only 24% (n=12) were wearing class 2 compression stockings. In the bivariate analysis class 2 compression hosiery usage for five days or more a week resulted in a statistically significant reduction in the time to recurrence but did not retain significance in the final model. A systematic review and meta-analysis³⁵ found class 2 compression stockings were more likely to reduce the incidence of recurrence than class 1 compression stockings. It was noted poor compliance rates reduced the quality of evidence and suggested that compliance decreases with higher grades of compression. In the current study 80% (n=40) of the sample reported they were prescribed compression and 60% (n=30) wore what they were prescribed. Unfortunately, some participants were prescribed a single layer of tubular elastic bandage. This bandage could have increased the concordance rate; however, there is no evidence a single layer of tubular elastic bandage can reduce the risk of recurrence. Another factor that could have increased concordance rates was the use of old compression stockings which are loose and easy to apply. While this did not reach significance in the current study, participants who had replaced their compression recently at the six-month timepoint were less likely to experience a recurrence.

Participants who had difficulty putting on and taking off their compression stockings were found to be significantly more likely to experience a recurrence at the bivariate level. Difficulty putting on compression stockings, while adding strength to the model did not reach statistical significance in the final model. Strength and dexterity can impede compression usage^36,37 and stocking applicators facilitate use.³⁸ A systematic review of the literature examining compliance with compression for chronic venous insufficiency found physical limitations led to difficulty with application and removal of compression and consequently a reduction in compliance.³⁹ Strength and dexterity were not examined in the current study and 74% of the participants did not use an applicator despite reporting difficulties with application and removal of their stockings. Evaluating the patient’s self-efficacy levels could provide a deeper understanding of the underlying reasons related to this passive behaviour. Previous studies have found high levels of self-efficacy were related to the regular use of compression.^23,40

Another finding possibly related to the low compression usage which retained significance in the final model was oedema in the study leg. Sixty-two percent of the participants in the current study had oedema in the study leg and were significantly more likely to experience a recurrence. This finding increases the strength of the literature on the relationship between oedema and recurrence as there is little evidence of a direct link. Venous oedema is an indication of venous hypertension⁴¹ and should signal the necessity for treatment and protective strategies. Burian et al⁴¹ examined wounds in chronic oedema and found that by controlling oedema the likelihood of a wound was reduced by 50%. An early study reported oedema to have a statistically significant association with recurrence at the bivariate level.⁴²

Unfortunately, due to the small sample size the study was underpowered and the relationship between history of previous multiple leg ulcers and recurrence reached statistical significance at the bivariate level only. However, despite this result it added strength to the model and was retained. This is not new knowledge^5,24 and suggests preventing the development of the first venous leg ulcer is crucial. Effective management in the early stages of the disease should prevent the trajectory progressing to ulceration.⁴³

Hypothyroidism was the only medical condition that attained statistical significance at the bivariate level in this study. The small number of participants with hypothyroidism were found to be less likely to experience a recurrence. A potential explanation for this unusual find was that all these participants reported they used compression stockings for at least four days a week. While this level of compression is not ideal,¹⁷ it was a likely contributor to their protection against recurrence.

Implications for practice

Self-efficacy and symptoms resulting from chronic venous disease have been found to predict the likelihood of a recurrent venous leg ulcer. These factors alert the need for additional preventive treatments, such as, changing the level of compression therapy. Competence in application and removal of compression stockings and confidence in managing preventive activities are essential attributes in avoiding a recurrence. An applicator should be considered to assist in overcoming difficulties with compression usage. History of multiple venous leg ulcers is a known predictor of recurrence. Therefore, avoiding the first recurrence is crucial and individuals with symptoms and history should be assessed and early intervention plans put in place.

Implications for future research

Larger studies examining the findings from this research will provide additional evidence to assist in prevention of recurrence. Multidisciplinary collaborative research, including randomised controlled trials, is also necessary to provide a broad focus on prevention and management of the disease.

Limitations

The sample size was small and is a limitation to the study. This could increase the possibility of a Type 1 error.⁴⁴ However, this study contributes to the limited available knowledge on venous leg ulcer recurrence, a topic requiring further examination. Other limitations include, the number of participants lost to follow-up, the reluctance to complete questionnaires, the necessity for phone interviews and the lack of vascular studies to accurately diagnose the severity of venous disease in these participants.

Conclusions

The results of this study revealed a high recurrence rate and low compression stocking usage. The significant relationship in the final model between self-efficacy self-care activities and recurrence could explain the reasons underlying this outcome and suggests it is pointless prescribing compression without first establishing if the patient is confident and able to use it. The remaining two significant relationships with recurrence in the final model, oedema and topical steroids imply the participants could be experiencing sustained uncontrolled venous hypertension. Recognition that these symptoms are flagging an impending recurrence is valuable information and should alert patients that they need to use compression to address the symptoms to reduce the likelihood of a recurrence. Recurrent venous leg ulcers are preventable skin and tissue injuries. Early recognition of factors predicting these wounds would reduce patient morbidity and health care costs.

Acknowledgements

We acknowledge the significant contribution of Helen Edwards, RN, PhD, Emeritus Professor, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Queensland, Australia.

Conflict of interest

The authors declared no conflicts of interest

Ethics statement

Ethics approval was gained from South Eastern Sydney Local Health District Human Research Ethics Committee Reference Number: 15/187(LNR/15/POWH/162) and Queensland University of Technology Human Research Ethics Committee Administrative Review Number: 1500000619. Informed written consent was provided by participants

Funding

The study was funded by a scholarship from the Wound Management Innovation Collaborative Research Centre. Money was used for study materials, travel and editorial support.

Author contribution

AS: study design, data collection, data analysis, synthesis and manuscript writing. KF: study design, data analysis, synthesis and manuscript writing.

Author(s)

Ann M Stewart, Kathleen Finlayson¹*
¹Centre for Healthcare Transformation, Queensland, University of Technology, Brisbane, Queensland, Australia

*Corresponding author email k.finlayson@qut.edu.au

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