Status:
TERMINATED
Effects of Temperature Control Liner Materials on Long-Term Outcomes of Prothesis Use
Lead Sponsor:
Goeran Fiedler
Collaborating Sponsors:
Widener University
United States Department of Defense
Conditions:
Artificial Limbs
Skin Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 material...
Detailed Description
Background: The proposed work will generate evidence-based practice guidance for temperature control liner technologies and allow providers to optimize care to Service members and Veterans with limb l...
Eligibility Criteria
Inclusion
- use of a prosthesis with liner suspension,
- at least one year of prosthesis use,
- a well-fitting socket,
- a matured residual limb (stable limb volume) that has not required socket modifications in the previous year,
- the ability to walk with the prosthesis outdoors without notable limitations (K-Level 3),
- stable weight,
- absence of acute medical conditions that would temporarily affect the ability to use prostheses.
Exclusion
- use of a non-standard liner size,
- current use of a PCM liner as the regular suspension system,
- known allergies against liner materials,
- any inability to understand the protocol and to comply with the associated tasks, such as maintaining a log of days when the prosthesis could not be used.
- anticipated provision of a new prosthesis or extended (longer than one month) absences from the region during the study period
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03428815
Start Date
February 4 2019
End Date
September 29 2020
Last Update
March 5 2021
Active Locations (1)
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1
Bakery Square MSPO labs
Pittsburgh, Pennsylvania, United States, 15206