Cost-effectiveness analysis of the geko™ device (an NMES technology) in managing venous leg ulcers in UK healthcare setting

Abstract

Objective: This study evaluates the cost-effectiveness of the geko device a neuromuscular electro-stimulator (NMES) technology with standard of care versus standard of care alone for venous leg ulcers treatment, from the UK National Health Service perspective over 12 months. Setting: Research was conducted across NHS UK facilities, primarily within community services and outpatient leg ulcer clinics, encompassing a total of 51 patients. Method: A partitioned survival model, based on a two-arm randomised controlled trial, assessed wound healing rates using Kaplan–Meier curves and parametric extrapolations over a 12–month time horizon. Costs were derived from UK reference costs the British National Formulary, and the Personal Social Services Research Unit (2021/22). The primary outcome measured was the incremental cost per quality-adjusted life–year gained. The geko device provides additional benefits by stimulating the lateral popliteal nerve, augmenting venous, arterial and microvascular flow. Results: The addition of the geko device to standard of care significantly enhanced outcomes, increasing healing probability by 68% compared to standard of care. This integration would result in a cost saving of £774.14 per patient when compared to the standard of care alone across the NHS. Economic analyses indicate that integrating the geko device into standard of care protocols would reduce the overall NHS expenditure on venous leg ulcer wound management by as much as 15%. The approach also positively impacted health–related quality of life. Conclusion: The geko™ device when used adjunctively with standard of care would be a cost-effective method for managing chronic venous leg ulcers within the NHS, improving healing rates and offering economic benefits.

Competing Interest Statement

KH, and RT have received investigator grants, honoraria and consulting fees from several medical device companies, including Firstkind Ltd.

Funding Statement

This study and economic model created to support the findings was funded by Firstkind Ltd, Daresbury, Cheshire, UK and by Health Analytical Solutions Ltd, Macclesfield, Cheshire, UK.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Our study utilised data from a published Randomised Controlled Trial (RCT), specifically "The impact of a new intervention for venous leg ulcers: A within-patient controlled trial" (https://onlinelibrary.wiley.com/doi/10.1111/iwj.14107). This data was used to inform our health economic analysis. Since this dataset was obtained from a published study, it required proper citation and usage in compliance with academic standards.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript

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