A clinical and economic evaluation of protease-modulating matrix interventions for diabetic foot and leg ulcers: Towards the development of treatment guidelines in the United Kingdom

Betts, April (2020) A clinical and economic evaluation of protease-modulating matrix interventions for diabetic foot and leg ulcers: Towards the development of treatment guidelines in the United Kingdom. Doctoral thesis (PhD), Manchester Metropolitan University.

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Abstract

Background: Wounds such as Diabetic foot ulcers (DFU) and leg ulcers (LU) are burdensome, reduce a patient’s quality of life (QoL) and require a lot of time, money, and resources to heal. Patients have access to many types of dressing, but no guidance exists identifying a preferred dressing regimen, in part due to lack of data supporting clinical and cost-effectiveness. This research investigates treatment of DFU and LU with protease-modulating matrix interventions with the intent of creating treatment guidelines. Methods: A multi-method research protocol was designed to include; systematic literature reviews; Delphi methodology expert panel; patient reported outcomes study; retrospective real-world data analysis; and a collection of economic modelling. Economic models include budget impact modelling, cost-consequence analysis, cost-utility and cost-effectiveness analysis, supported by data collected in the four previous studies. Statistical and sensitivity analysis have been performed where necessary and external guidelines and best practice followed to assure high-quality research. Results: The studies showed the variance in care; the efficacy of the sucrose-octasulfate dressing and the burden of DFU and LU. Economic modelling found that the sucroseoctasulfate dressing was both a clinically and cost-effective option; improving time to healing and reducing the cost of care; whilst the incidence of adverse events such as infection or amputation was less. The results of this research have been included in guidance published by the National Institute for Health and Care Excellence (NICE). Discussion: The most cost-effective dressing is not the one with the lowest acquisition cost. Scenario analysis showed the sucrose-octasulfate dressing as cost-saving when a comparator was zero cost; demonstrating the impact of improved healing time on reducing overall costs. Patients, healthcare professionals and payers should be aware of the newly published NICE guidance; to accelerate healing, reduce cost and improve QoL for patients with DFU or LU.