INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protoco
Date
2019-03-23Author
Subject
Metadata
Show full item recordAbstract
<jats:sec><jats:title>Introduction</jats:title><jats:p>Foot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.</jats:p></jats:sec><jats:sec><jats:title>Aim</jats:title><jats:p>This study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.</jats:p><jats:p>Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.</jats:p></jats:sec><jats:sec><jats:title>Trials registration number</jats:title><jats:p>ISRCTN16011830; Pre-results.</jats:p></jats:sec>
Collections
Publisher
Place of Publication
Journal
Volume
Issue
Pagination
Number
Recommended, similar items
The following license files are associated with this item:
Related items
Showing items related by title, author, creator and subject.
-
Pregabalin for treating Painful Diabetic Neuropathy in Type 1 and Type 2 Diabetic Patients
Kruckow, K. (University of Plymouth, 2012)Background: It has been estimated that chronic painful diabetic neuropathy (PDN) affects 1 in 6 (16.2%) of all diabetic patients (Diabetes UK, 2010) yet the symptoms of PDN continue to present a huge challenge in its ... -
Hyperglycaemia-related complications at the time of diagnosis can cause permanent neurological disability in children with neonatal diabetes
Day, Jacob; Flanagan, SE; Shepherd, MH; Patrick, AW; Abid, N; Torrens, L; Zeman, AJ; Patel, KA; Hattersley, AT (WileyEngland, 2017-07)BACKGROUND: Children with neonatal diabetes often present with diabetic ketoacidosis and hence are at risk of cerebral oedema and subsequent long-term neurological deficits. These complications are difficult to identify ... -
Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial
Hatton, AL; Gane, EM; Maharaj, JN; Burns, J; Paton, Joanne; Kerr, G; Rome, K (BMJ Publishing GroupEngland, 2019-07-17)<jats:sec><jats:title>Introduction</jats:title><jats:p>Peripheral neuropathy is a major risk factor for falls in adults with diabetes. Innovative footwear devices which artificially manipulate the sensory environment at ...