NCT02124915

Brief Summary

The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

April 24, 2014

Last Update Submit

August 22, 2017

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

prosthetic socketamputee

Outcome Measures

Primary Outcomes (1)

  • Residual limb fluid volume

    1 month

Secondary Outcomes (1)

  • Activity

    1 month

Other Outcomes (2)

  • Comfort and prosthesis satisfaction

    1 month

  • Gait

    1 month

Study Arms (1)

Transtibial amputees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Transtibial amputees

You may qualify if:

  • transtibial amputee
  • at least 18 months post amputation
  • over 18 years of age
  • capable of treadmill walking and 90 seconds of continuous standing

You may not qualify if:

  • skin breakdown on the residual limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98075, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 28, 2014

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

US(1)