Randomised controlled trial comparing the efficacy of foot orthoses produced by traditional and digital design processes, to reduce pressure and assess the impact on clinical practice

niversity of Salford0 sites57 target enrollmentNovember 4, 2015

Overview

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30636974 results (added 16/01/2019)

Registry

who.int

Start Date

November 4, 2015

End Date

November 30, 2016

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Salford

•1\. Aged between 40 and 85 years
•2\. Have diabetes diagnosed by a medical practitioner
•3\. Have modular or bespoke (non standard) footwear provided by the orthotics department
•4\. Have all normal foot structures present
•5\. Be able to walk without a stick for 100 metres
•6\. Have sensory neuropathy as assessed by 10mg monofilament and vibratory perception at 3 of 10 sites on the foot and ankle
•7\. Have detectable pulse in foot and ankle (palpation or Doppler)
•8\. Must be capable of providing informed consent to participate

•1\. Have had prior foot or ankle surgery
•2\. Have had prior major injuries to lower limb (e.g. fractures requiring internal fixation, skin grafts)
•3\. Have prior or active chronic foot or leg ulceration and without episode of ulceration within last 2 years.
•4\. Require heel pressure reduction intervention
•5\. Have had prescription foot orthoses via the orthotics department in the last 12 months
•6\. Co\-morbidities (ischemia, renal, charcot arthorpathy)