NCT01546311

Brief Summary

The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

March 2, 2012

Last Update Submit

March 2, 2012

Conditions

Amputation

Keywords

prosthetic socketresidual limb volume fluctuationinstantaneous bladder

Study Arms (1)

lower limb amputees

Device: Pro Active Dynamic Accommodating Socket

Interventions

Pro Active Dynamic Accommodating SocketDEVICE

Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb

lower limb amputees

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons with transfemoral or transtibial amputation who have been using a prosthesis for at least one month will be recruited for this study.

You may qualify if:

  • transfemoral or transtibial amputation
  • unilateral or bilateral amputation
  • stable residual limb volume
  • read, write, and speak English for proper consent and responding to questionnaire

You may not qualify if:

  • evidence or history of residual limb skin conditions such as irritation or sores
  • presence of phantom limb pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liberating Technologies, Inc

Holliston, Massachusetts, 01746, United States

RECRUITING

Next Step O&P

Newton, Massachusetts, 02461, United States

ENROLLING BY INVITATION

Study Officials

  • Kristen J LeRoy

    Infoscitex Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Klodd

CONTACT

508-893-6363liz.klodd@liberatingtech.com

Kristen LeRoy

CONTACT

781-890-1338kleroy@infoscitex.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group Leader, Biomedical Devices

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

US(2)