Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design

Status unconfirmed · Phase 2

Conditions studied: Amputation

In brief

People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.

Key facts

Study ID

NCT00061217

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

59

Starts

2001-04-01

Expected to finish

2005-03-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral transtibial amputation
• Mature residual limbs (i.e., no major change in stump volume due to atrophy or other destabilizing factors)
• Continuously worn a prosthesis for at least 1 year prior to study entry
• Scheduled for a new prosthesis
• Independent ambulation
• No acute health problems

You may not qualify if…

• Constant recurring prosthetic problems (i.e., adherent scar tissue, neuromas, bony protuberances at distal end)
• Requires gel inserts, additional ply socks, or other atypical fitting components or methods
• Health status that prohibits patient from performing graded exercise test

Where it is running

• Jack R. Engsberg — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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