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Effects of Temperature Control Liner Materials on Long-Term Outcomes of Prothesis Use

NCT03428815 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-03-05

Study results available
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Summary

This clinical trial will compare how many days per year people with lower limb prosthesis do not wear their prosthesis when fitted with a conventional liner and a liner made with phase change materials.

Conditions

  • Artificial Limbs
  • Skin Diseases

Interventions

DEVICE

Prosthesis suspension liner

Liners out of phase change material will be fitted

Sponsors & Collaborators

  • Widener University

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Goeran Fiedler

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2020-08-30
Completion
2020-09-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428815 on ClinicalTrials.gov