NCT03428815

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 materials.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 5, 2021

Completed
Last Updated

March 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

February 5, 2018

Results QC Date

January 25, 2021

Last Update Submit

February 15, 2021

Conditions

Artificial LimbsSkin Diseases

Outcome Measures

Primary Outcomes (1)

  • Days Without Prosthesis

    Days with less than 10% of prosthesis steps than the individual's daily average across the study period. Days without prosthesis are prorated to a full year (365 days) for comparison purposes.

    6 months

Secondary Outcomes (1)

  • Average Daily Step Count

    6 months per intervention

Study Arms (2)

PCM liner

EXPERIMENTAL

Willowwood Smart Temp Liner

Device: Prosthesis suspension liner

regular liner

ACTIVE COMPARATOR

User's regular prescribed liner

Device: Prosthesis suspension liner

Interventions

Prosthesis suspension linerDEVICE

Liners out of phase change material will be fitted

PCM linerregular liner

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakery Square MSPO labs

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Publications (1)

  • Fiedler G, Singh A, Zhang X. Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol. Trials. 2020 Jan 10;21(1):61. doi: 10.1186/s13063-019-3920-4.

    PMID: 31924257DERIVED

Related Links

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Limitations and Caveats

Covid-19 pandemic invalidated assumptions about the representativeness of daily step counts and led to early termination of enrollment and ongoing data collection. The remaining sample size was insufficient for the planned analyses beyond descriptive statistics.

Results Point of Contact

Title
Dr. Goeran Fiedler
Organization
University of Pittsburgh
gfiedler@pitt.edu
14126246475

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

February 4, 2019

Primary Completion

August 30, 2020

Study Completion

September 29, 2020

Last Updated

March 5, 2021

Results First Posted

March 5, 2021

Record last verified: 2021-02

Locations

US(1)