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

Stopped early · Not applicable

Conditions studied: Artificial Limbs, Skin Diseases

In brief

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.

Key facts

Study ID

NCT03428815

Run by

Goeran Fiedler

People needed

42

Starts

2019-02-04

Expected to finish

2020-09-29

Last updated by the study team

2021-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Bakery Square MSPO labs — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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