NCT02124876

Brief Summary

The purpose of this study is to quantify residual limb fluid volume changes between morning and afternoon hours, and to determine if fluid volume change is correlated with activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

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

June 1, 2013

Completed
11 months 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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2014

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

April 24, 2014

Last Update Submit

November 2, 2020

Conditions

Diurnal Residual Limb Fluid Volume Fluctuation

Keywords

amputeeprosthetics

Outcome Measures

Primary Outcomes (1)

  • Residual limb fluid volume

    1 day

Secondary Outcomes (1)

  • Duration of walking and moving

    1 day

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 amputee currently using prosthetic limbs

You may qualify if:

  • transtibial amputation
  • at least 18 months after amputation surgery
  • ability to walk on a treadmill and stand for 90 seconds

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

Study Design

Study Type
observational
Observational Model
COHORT
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

June 1, 2013

Primary Completion

June 6, 2014

Study Completion

June 6, 2014

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

US(1)