About this trial
To evaluate the clinical effectiveness of siliconepads and if they could be an alternative to felted foam used in offloading high risk pressure areas in the plantar forefoot region using plantar pressure measurements.
Also user experience will be evaluated which is an important criterion in the use of this new type of offloading. Comfort, convenience and functionality of both felted foam and siliconepads will be tested to evaluate if siliconepads are more appropriate then felted foam.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diabetes, Peripheral neuropathy, able to walk 5 minutes, able to sign informed consent
Disqualifiers
No diabetes, No neuropathy, not able to walk without walking aid, not able to sign informed consent
Trial population
Diabetic patients with peripheral neuropathy
Trial design
Cohort
Prospective
Treatments tested in this trial
Siliconepad
DevicePlantar pressure measurement
Felted foam
DevicePlantar pressure measurement
Treatment groups
Trial outcomes
Primary outcomes
Plantar pressure reduction
Achieve a plantar pressure decrease of 25%, leading to less than 200kpa under the 2nd caput metatarsal region after wearing siliconepads in comparison to barefoot plantar pressure measurement at baseline and after 48 hours. Achieve a plantar pressure decrease of 25% or less then 200kpa in the 2nd caput metatarsal region after wearing felted foam in comparison to barefoot plantar pressure measurement at baseline and after 48 hours.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: