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NCT07266077

Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations

Not yet recruiting NA Last updated 5 December 2025
What this trial tests

NA trial testing Fillauer Slope Adaptive Foot in Amputation in 30 participants. Not yet recruiting.

Timeline
1 April 2026
Primary endpoint
1 April 2029
1 April 2029

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposesupportive care
Enrollment30
Start date1 April 2026
Primary completion1 April 2029
Estimated completion1 April 2029
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 89, any sex, with Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact participation in daily and recreational activities. The investigative group has designed a novel Slope Adaptive Foot (SAF) that is mechanically passive, capable of slope adaption on every step of walking, and maintains high levels of energy storage and return. Pilot testing of the SAF with Veterans has generated excellent results to date, with comments suggesting potential improvements in participation. This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical hydraulic foot in a cross-over randomized controlled trial. Using mixed-methods, the investigators will also collect long-term data of Veterans using their preferred foot to inform the development of evidence-based education materials for use in clinical decision making.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Amputation

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing