Insole Optimisation for Ulcer Prevention: a Feasibility Trial
Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates.
Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration.
However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.
Device: Optimised instant offloading insole
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prevention of Foot Ulcer Recurrence in People With Diabetes Using an In-shoe Pressure Measurement Technology: A Randomised Control Trial Feasibility Study|
- ulcer recurrence rates [ Time Frame: 6 months ]
- peak pressure reduction with the addition of the intervention [ Time Frame: Issue and 6 months ]
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|Experimental: Insole optimised with inshoe analysis||Device: Optimised instant offloading insole|
|Active Comparator: Routine insole provision||Device: Optimised instant offloading insole|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01948479
|Contact: Joanne Paton, PhD||01752 firstname.lastname@example.org|
|Derriford Hospital||Not yet recruiting|
|Plymouth, Devon, United Kingdom, PL6 8BH|
|Contact: Graham Bruce email@example.com|
|Sub-Investigator: Graham Bruce|