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A Mixed Methods Feasibility Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

Hitchman, Louise; Totty, Joshua; Cai, Paris; Smith, George; Carradice, Daniel; Chetter, Ian

Authors

Louise Hitchman

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Mr Josh Totty J.Totty@hull.ac.uk
NIHR Clinical Lecturer in Plastic Surgery

Paris Cai

George Smith

Daniel Carradice

Ian Chetter



Abstract

Aims:
The purpose of this mixed methods feasibility study was to assess the feasibility of delivering ESWT to patients with DFUs. It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT may offer any patient reported benefits.
Methods:
A single centre mixed methods feasibility study. Patients with a DFU who met the eligibility criteria underwent ESWT 3 times in over 7 days. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFU healed at 12 weeks and quality of life. Semi-structured interviews explored participants experience of undergoing ESWT.
Results:
22.6% (24/106) of patients screened were recruited. The mean attendance to clinic was 90.9% and 65.1% to follow up. The mean score for acceptability and tolerability was 9.86 (SD 0.48, 95% CI 9.62-10.01) and 9.15 (SD 2.57, 95% CI 7.87-10.42) respectively. There were no serious adverse events or side effects. 45.5% of DFU healed during follow up and quality of life scores improved until 8 weeks. Key themes identified from the qualitative interviews were desire for the fast healing, improved quality of life, new treatments must be flexible and accessible on transport.
Conclusion:
This study has shown it is possible to recruit and retain patents into this research. This study supports development of a large randomised control trial to determine the clinical and cost effectiveness of ESWT for DFU healing.

Citation

Hitchman, L., Totty, J., Cai, P., Smith, G., Carradice, D., & Chetter, I. (2021). A Mixed Methods Feasibility Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers. Journal of Wound Care, 108(supp.6), Article znab259.1127. https://doi.org/10.1093/bjs/znab259.1127

Journal Article Type Article
Acceptance Date Sep 10, 2021
Online Publication Date Oct 12, 2021
Publication Date 2021-09
Deposit Date Apr 26, 2022
Publicly Available Date Oct 27, 2022
Journal Journal of Wound Care
Print ISSN 0969-0700
Publisher MA Healthcare
Peer Reviewed Peer Reviewed
Volume 108
Issue supp.6
Article Number znab259.1127
DOI https://doi.org/10.1093/bjs/znab259.1127
Keywords Diabetic foot ulcer; Cost effectiveness; Follow-up; Randomization; Wound healing; Quality of life; Quality improvement; Extracorporeal shockwave therapy; Adverse event; Patents; Primary outcome measure
Public URL https://hull-repository.worktribe.com/output/3984165

Files

Accepted manuscript (371 Kb)
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Copyright Statement
© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved.





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