Insole Optimisation for Ulcer Prevention: a Feasibility Trial
NCT ID: NCT01948479
Last Updated: 2013-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-01-31
2015-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Insole optimised with inshoe analysis
Optimised instant offloading insole
Routine insole provision
Optimised instant offloading insole
Interventions
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Optimised instant offloading insole
Eligibility Criteria
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Inclusion Criteria
* Male or Female, aged 30 years or above
* Diagnosed with Diabetes Mellitus
* Recently healed/healing target ulcer on the weight-bearing surface of the foot
* Neuropathic (Mild to moderate DPN defined as insensitivity of a 10 g monofilament at 1-3 sites in the following locations: hallux, 1st, 3rd, and 5th metatarsal heads (Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK: Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care 2008;31:1679-1685)
* Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion Criteria
* None healing foot ulcer at another site that requires targeted off-loading.
* Unable to walk 5 metres with/without walking aid
* Peripheral vascular disease (non-re-constructible vascular disease as determined by arterial duplex and clinically assessed by a vascular consultant)
* Unwilling to wear therapeutic footwear
* Where amputation has been part of the current episode of care and includes ulceration site.
30 Years
ALL
No
Sponsors
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University Hospital Plymouth NHS Trust
OTHER
University of Plymouth
OTHER
Responsible Party
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Joanne Paton
NIHR Clinical Research Fellow
Locations
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Derriford Hospital
Plymouth, Devon, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Graham Bruce
Role: primary
Other Identifiers
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PatonRCT02
Identifier Type: -
Identifier Source: org_study_id