Angioplasty and stenting for below the knee ulcers in diabetic patients: protocol for a systematic review.

Background: The worldwide incidence and prevalence of diabetes mellitus (DM) are increasing. DM has a high social and economic burden due to its complications and associated disorders. Peripheral arterial disease (PAD) is closely related to DM. More than 85% of patients with DM will develop PAD in their lifetime, and between 10 and 25% of patients with DM will have a foot ulcer. In such cases, it is important to determine for each patient whether it is necessary and feasible to revascularise the affected limb as well as the optimal technique. Percutaneous transluminal angioplasty (PTA) is designed to restore blood flow through the vessel lumen by various devices including balloons, drug-coated balloons, bare stents, drug-eluting stents and endovascular atherectomes. This systematic review aims to evaluate the effects of PTA in the treatment of lower limb arterial ulcers in diabetic patients.

Methods: We will search randomised controlled trials (RCTs) and quasi-RCTs in the following databases (e.g., MEDLINE via PubMed, EMBASE, Lilacs, Cochrane Central Register of Controlled Trials, Ibecs, CINAHL, AMED, World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov , and OpenGrey). Our search strategy will use the following free-text terms and controlled vocabulary (e.g., Emtree, MeSH) for 'foot ulcer', 'leg ulcer', 'diabetic foot', 'Peripheral Arterial Disease', 'Diabetes Complications', 'Peripheral Vascular Diseases', 'critical limb ischemia', 'below the knee ulcer', 'angioplasty', 'stents', 'stenting', and 'endovascular procedures'. There will be no limits on date or language of publication. Two authors will, independently, select studies and assess the data from them. Risks of bias (RoB) of included studies will be evaluated using the Cochrane's RoB tool. If possible, we will perform and report structured summaries of the included studies and meta-analyses. Results are not available as this is a protocol for a systematic review, and we are currently in the phase of building a sensitive search strategy.

Discussion: While there are several available endovascular techniques for revascularisation, it is unclear which technique has better outcomes for ulcers below the knee in diabetic patients. A systematic review is required to validate and demonstrate these techniques and their outcomes to allow an evidence-based clinical decision.

Systematic Review Registration: PROSPERO CRD42017065171.