Chronic lower limb ulcer (CLLU) is a chronic wound of the leg that shows no tendency to heal after 3 months of appropriate treatment or is still not fully healed at 12 months.
Ulcers of skin can result in complete loss of some layers of the skin and even subcutaneous fat. Chronic ulceration of the lower legs is a relatively common condition amongst adults, and ulcer symptoms usually include increasing pain, friable granulation tissue, foul odour, and wound breakdown instead of healing.
The burden of wound management to the NHS in the UK in 2012/2013 was estimated to be at a cost of £5.3 billion among 2.2 million patients it is therefore important to recognise CLLU patient characteristics and associated health care resource use and costs.
This study aims to determine the size of the population group with CLLU in England and categorise it group based on healing agent prescribed. We shall then describe each group by its demographic and clinical profile and then determine health care resource use and costs associated with each group of patients.
This study will be able to provide an in-depth understanding of the demographic and clinical characteristics of this patient group, whilst also assessing the benefit of certain type of prescriptions in each cohort of CLLU patients. This will trigger further research and inform health policy, treatment and clinical management options, especially targeting patients with specific risk factors in turn enabling better outcomes and reducing costs and healthcare resource usage associated with CLLU.
Chronic lower limb ulcers/wounds (CLLU) including diabetic and venous foot ulcers account for a substantial health burden nationally, with an estimated cost representing a total of 2% expenditure of the NHS. This cost burden includes primary care, secondary care stays, surgeries and prescriptions. Traditionally, saline or tap water has been used to clean ulcers prior to applying dressings. Alternatives to saline or tap water include propylbetaine-polihexanide solution (Prontosan™) a wound cleansing agent used to prevent and remove biofilms.
We are interested in conducting a comparative study of the Healthcare Resource Utilisation (HRU) of patients with CLLU prescribed Prontosan and saline solution demonstrating that the use of Prontosan leads to better HRU, costs and improved clinical outcomes including faster healing and reduced occurrence of infection. This study will provide evidence to whether the use of Prontosan leads to lower costs in real-world practice.
This shall be a retrospective cohort study on a clinical healthcare dataset linked to an administrative healthcare dataset. This study shall determine patients that have been diagnosed with CLLU and
describe their demographic and clinical characteristics as well as treatment received and healthcare burden and cost.
The study will also involve a comparative element with the aim of comparing outcomes between patients prescribed Prontosan (including solution and gel) compared to those prescribed saline solution with a null hypothesis that a difference exists within the two cohorts. This will be modelled using a multivariate Cox proportional hazards regression. Kaplan-Meier analysis will be performed to compare time-event-for wound healing between Prontosan vs. saline prescribed patients.
The study design has been chosen as it is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data for procedures, demographics, costs, complications, readmissions and resource use.
Prevalence of chronic lower limb ulcers (CLLU); Prevalence of CLLU by wound healing agent; Demographics (Mean and median age on inclusion, gender, total, mean and median follow-up and socioeconomic status); Clinical characteristics (Time to diagnosis, Charlson co-mobidity score, lung function, smoking status, comorbidities, type of ulcers, mobility restriction, previous ulcers, Ankle Brachial Pressure); treatment pathway(prescriptions issued in primary care, time from diagnosis to treatment); Healthcare resource outcomes (procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes (mortality, referrals, wound healing, wound related infections, prescriptions in primary care (bandages, analgesics, antibiotics, dressings), amputations, tissue viability)
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Jennifer Davidson - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Archie Farrer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Judith Ruzangi - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Mico Hamlyn - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Shea O'Connell - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation