The Pressure Relieving Capacity of Siliconepads Compared to Felted Foam to Relieve Caput Metatarsal 2 in a Population With Diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity Hospital, Ghent

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Siliconepad

    Device

    Plantar pressure measurement

  • Felted foam

    Device

    Plantar pressure measurement

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
48 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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