CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Traditional fabricated prosthetic socket +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01155024
NCT01155024Phase 2Completed
CompareCT.gov

Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Ohio Willow Wood·interventional·Posted Jul 1, 2010·Updated Jan 11, 2012

In Brief

A Phase 2 clinical trial evaluating Traditional fabricated prosthetic socket and Direct manufactured (DM) prosthetic socket for Amputation. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2010
Enrollment StartSep 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.0 years ago

Interventions

Traditional fabricated prosthetic socketdevice

A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.

Direct manufactured (DM) prosthetic socketdevice

A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)