NCT07172763

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Oct 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Oct 2028

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

October 8, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

September 8, 2025

Last Update Submit

September 16, 2025

Conditions

Diabete MellitusPeripheral Neuropathy

Keywords

DiabetesSensory peripheral neuropathySiliconepadsFelted foamPlantar pressure measurement

Outcome Measures

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.

    48 hours

Interventions

SiliconepadDEVICE

Plantar pressure measurement

Felted foamDEVICE

Plantar pressure measurement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients with peripheral neuropathy

You may qualify if:

  • Diabetes, Peripheral neuropathy, able to walk 5 minutes, able to sign informed consent

You may not qualify if:

  • No diabetes, No neuropathy, not able to walk without walking aid, not able to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusPeripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Caren Randon

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start

October 8, 2025

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

October 30, 2028

Last Updated

September 22, 2025

Record last verified: 2025-09