Clinical Predictors of Leg Ulcer Healing
Clinical Predictors of Leg Ulcer Healing
Background Identification of factors associated with healing can help in understanding the causes of delayed healing in chronic leg ulceration, and can allow for programmes to be developed to modify these factors to improve patient outcomes.
Objectives To determine factors associated with healing in patients with chronic leg ulceration of all types within a defined patient population.
Methods The patients were identified within the combined acute/community leg ulcer service within Wandsworth Primary Care Trust. All identified patients agreed to be interviewed and those who were able underwent clinical and noninvasive testing to determine the cause of the ulceration. Follow ups were to a maximum of 48 weeks, with time to healing given as the principal outcome measure. Analysis was by the Cox proportional hazards model for both univariate and multivariate analysis. Results were expressed as hazard ratio with 95% confidence intervals derived from the models.
Results In total, 113 patients took part in this study. Univariate analysis revealed statistically significant differences for delayed healing according to the ulcer duration (P = 0·002), complexity of the ulcer aetiology (P = 0·035), presence of lipodermatosclerosis (P = 0·02), history of deep vein thrombosis (DVT) (P = 0·03) and thrombophlebitis (P = 0·03). Multivariate analysis showed that ulcer duration (P = 0·014), DVT (P = 0·008) and a lack of Pseudomonas on wound swab (P = 0·005) were independently associated with delayed healing.
Conclusions The results indicate the complexity of determining risk factors for poor healing in patients with chronic leg ulceration. There appears to be little scope for interventions to improve healing from the factors identified.
Chronic leg ulceration is a common health problem, particularly of the elderly. Studies have indicated that approximately 100 000 patients have the problem at any one time in the U.K., with four times this number in the U.S.A. Despite developments in the assessment and management of patients with ulceration, there remains a small but significant group of patients who appear to have prolonged healing, despite best practice. Some of the earliest work in identifying risk factors for delayed healing demonstrated that routinely collected clinical data could be used to identify factors that might predispose patients to a prolonged ulcer diathesis.
The identification of risk factors for delayed healing offers an opportunity to determine realistic outcomes for patients. This might also be linked into decisions on alternative interventions when standard care may be insufficient to achieve healing. Patients with intractable ulcers are likely to be resource intensive, even when the treatment offered may only maintain their ulcer in its present state. High-cost innovative technologies such as tissue-engineered skin and growth factors need to be targeted to appropriate patient groups, who are likely to show the most benefit. Risk factors for poor healing may be used to identify these patients so that these alternatives may be considered.
The patient risk factor profile can also offer benefits to the healthcare system, which requires information on the burden of care in order to inform decisions on the needs of the population and the allocation of appropriate resources. Moreover, there is a potential for modification of certain factors, in order to improve patient outcomes. Traditional approaches to care have generally revolved around either medical or nursing professionals' provision of care, rather than considering the potential role that the wider multidisciplinary team may have on outcome. Interventions by other health professionals that may modify risk factors could be important to the chronic nonhealing group.
Some of the work on risk factors is over 20 years old, and it is likely that there have been significant changes in the population profiles of patients, and also in the development of services and provision of effective treatment. As an example of this the use of high-compression bandaging was rarely used in the U.K. in the early 1990s. Innovations in service development, and the availability of Doppler ultrasound and high-compression bandaging through prescription, have made access to this evidence-based treatment available to all. It is still largely unknown what proportion of patients with venous ulceration receives appropriate high-compression treatment. Clinical cure is rarely considered in patients with chronic ulceration. A trial of superficial vein surgery determined that surgical correction did not lead to improved healing times, but was associated with reduced recurrence. Despite surgical correction there remains a significant proportion whose ulcers recur, or who may not be amenable to surgery in the first place. Without correction of the underlying pathology clinical cure is unlikely be achievable in all patients. Compression bandaging therapy is referred to as a short-term therapy to induce ulcer healing. Most studies follow patients to either 12 or 24 weeks. Anecdotal clinical opinion would suggest that long-term treatment leads to a worsening of ankle function which is restricted using this treatment. Therefore, the treatment itself may be contributing to nonhealing in this situation.
Most risk factor work has been undertaken in discrete samples of the ulcer population, most notably in patients with uncomplicated venous ulceration. Recent work has highlighted that uncomplicated venous ulceration represents a relatively small proportion of the total population in established leg ulcer services. Little information on risk factors has been ascertained in the ulcer population as a whole, nor in selected groups other than those with pure venous ulceration. Moreover, there is some evidence that as services develop the patient population changes, patients increasingly having other concurrent diseases and reduced mobility. As the services develop patients who remain tend to be more elderly and complex. Studies indicate that after age 65 years the ulcer aetiology becomes more complex. Established risk factor profiles may not be relevant to this patient group.
There is increasing interest in the identification of risk factors for poor healing and the value of prognostic indicator tools. These may be of value to healthcare organizations to allow for more accurate planning of services, and to identify whether outcomes are appropriate for the patient population being cared for within their service.
The aim of this study was to determine clinical risk factors for delayed healing in patients with chronic leg ulceration within an established leg ulcer service in the U.K.
Abstract and Introduction
Abstract
Background Identification of factors associated with healing can help in understanding the causes of delayed healing in chronic leg ulceration, and can allow for programmes to be developed to modify these factors to improve patient outcomes.
Objectives To determine factors associated with healing in patients with chronic leg ulceration of all types within a defined patient population.
Methods The patients were identified within the combined acute/community leg ulcer service within Wandsworth Primary Care Trust. All identified patients agreed to be interviewed and those who were able underwent clinical and noninvasive testing to determine the cause of the ulceration. Follow ups were to a maximum of 48 weeks, with time to healing given as the principal outcome measure. Analysis was by the Cox proportional hazards model for both univariate and multivariate analysis. Results were expressed as hazard ratio with 95% confidence intervals derived from the models.
Results In total, 113 patients took part in this study. Univariate analysis revealed statistically significant differences for delayed healing according to the ulcer duration (P = 0·002), complexity of the ulcer aetiology (P = 0·035), presence of lipodermatosclerosis (P = 0·02), history of deep vein thrombosis (DVT) (P = 0·03) and thrombophlebitis (P = 0·03). Multivariate analysis showed that ulcer duration (P = 0·014), DVT (P = 0·008) and a lack of Pseudomonas on wound swab (P = 0·005) were independently associated with delayed healing.
Conclusions The results indicate the complexity of determining risk factors for poor healing in patients with chronic leg ulceration. There appears to be little scope for interventions to improve healing from the factors identified.
Introduction
Chronic leg ulceration is a common health problem, particularly of the elderly. Studies have indicated that approximately 100 000 patients have the problem at any one time in the U.K., with four times this number in the U.S.A. Despite developments in the assessment and management of patients with ulceration, there remains a small but significant group of patients who appear to have prolonged healing, despite best practice. Some of the earliest work in identifying risk factors for delayed healing demonstrated that routinely collected clinical data could be used to identify factors that might predispose patients to a prolonged ulcer diathesis.
The identification of risk factors for delayed healing offers an opportunity to determine realistic outcomes for patients. This might also be linked into decisions on alternative interventions when standard care may be insufficient to achieve healing. Patients with intractable ulcers are likely to be resource intensive, even when the treatment offered may only maintain their ulcer in its present state. High-cost innovative technologies such as tissue-engineered skin and growth factors need to be targeted to appropriate patient groups, who are likely to show the most benefit. Risk factors for poor healing may be used to identify these patients so that these alternatives may be considered.
The patient risk factor profile can also offer benefits to the healthcare system, which requires information on the burden of care in order to inform decisions on the needs of the population and the allocation of appropriate resources. Moreover, there is a potential for modification of certain factors, in order to improve patient outcomes. Traditional approaches to care have generally revolved around either medical or nursing professionals' provision of care, rather than considering the potential role that the wider multidisciplinary team may have on outcome. Interventions by other health professionals that may modify risk factors could be important to the chronic nonhealing group.
Some of the work on risk factors is over 20 years old, and it is likely that there have been significant changes in the population profiles of patients, and also in the development of services and provision of effective treatment. As an example of this the use of high-compression bandaging was rarely used in the U.K. in the early 1990s. Innovations in service development, and the availability of Doppler ultrasound and high-compression bandaging through prescription, have made access to this evidence-based treatment available to all. It is still largely unknown what proportion of patients with venous ulceration receives appropriate high-compression treatment. Clinical cure is rarely considered in patients with chronic ulceration. A trial of superficial vein surgery determined that surgical correction did not lead to improved healing times, but was associated with reduced recurrence. Despite surgical correction there remains a significant proportion whose ulcers recur, or who may not be amenable to surgery in the first place. Without correction of the underlying pathology clinical cure is unlikely be achievable in all patients. Compression bandaging therapy is referred to as a short-term therapy to induce ulcer healing. Most studies follow patients to either 12 or 24 weeks. Anecdotal clinical opinion would suggest that long-term treatment leads to a worsening of ankle function which is restricted using this treatment. Therefore, the treatment itself may be contributing to nonhealing in this situation.
Most risk factor work has been undertaken in discrete samples of the ulcer population, most notably in patients with uncomplicated venous ulceration. Recent work has highlighted that uncomplicated venous ulceration represents a relatively small proportion of the total population in established leg ulcer services. Little information on risk factors has been ascertained in the ulcer population as a whole, nor in selected groups other than those with pure venous ulceration. Moreover, there is some evidence that as services develop the patient population changes, patients increasingly having other concurrent diseases and reduced mobility. As the services develop patients who remain tend to be more elderly and complex. Studies indicate that after age 65 years the ulcer aetiology becomes more complex. Established risk factor profiles may not be relevant to this patient group.
There is increasing interest in the identification of risk factors for poor healing and the value of prognostic indicator tools. These may be of value to healthcare organizations to allow for more accurate planning of services, and to identify whether outcomes are appropriate for the patient population being cared for within their service.
The aim of this study was to determine clinical risk factors for delayed healing in patients with chronic leg ulceration within an established leg ulcer service in the U.K.
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