Abstract
Background: Effective interventions to improve diabetic foot ulcer (DFU) healing are urgently required. Extracorporeal shockwave therapy (ESWT) has the potential to transform DFU care, but is limited by uncertainties around clinical effectiveness and optimal dosing regimen. This protocol outlines the methodology of a systematic review that will address these unknowns. Methods: Databases and the grey literature will be searched for randomised controlled trials (RCTs) comparing ESWT plus standard ulcer care to standard ulcer care ± sham ESWT in patients with a DFU. The primary outcome of the review is time to ulcer healing. Two independent reviewers will screen search results against pre-determined eligibility criteria and extract data onto a pre-piloted spreadsheet. A meta-analysis is planned to compare time to healing for ESWT versus standard care and different doses of ESWT. The Risk of Bias 2 and GRADE tool will be used to assess the quality of the evidence. Outputs, dissemination, impact: The review will provide an estimate of the effect of ESWT on DFU healing and the impact of the ESWT dose on DFU healing. The systematic review will be submitted for publication in a peer-reviewed journal. A plain English summary will be produced. Outputs from the review will guide patient care and research.
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