Recruiting

PADS

Sponsor:

Infoscitex Corporation

Code:

NCT01546311

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pro Active Dynamic Accommodating Socket

Study Details

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.

Conditions

Amputation

Study ID

NCT01546311

Start date

Jan, 2012

Status verified date

Mar, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

5 participants

Anticipated

Interventions and Outcome Measures

Arms

lower limb amputees

Interventions

Pro Active Dynamic Accommodating Socket

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

Central Contacts and Locations

Central contacts

Elizabeth Klodd

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

Kristen LeRoy

781-890-1338kleroy@infoscitex.com

Locations

Liberating Technologies, Inc

Recruiting

Holliston, Massachusetts, United States, 01746

Contacts

Elizabeth Klodd

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

More Information

Sponsor

Infoscitex Corporation

Last update posted

Mar 7, 2012

Last verified

Mar, 2012

Keywords

  • prosthetic socket
  • residual limb volume fluctuation
  • instantaneous bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Infoscitex Corporation on 2012-03-07.