Phase 2 N=10 Randomized Single-blind Treatment

Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Amputation

Bottom Line

View on ClinicalTrials.gov: NCT01155024 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2012

Primary outcome: Primary: Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting — 9; 8.7 score on scale — p=>0.4

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Traditional fabricated prosthetic socket (Device); Direct manufactured (DM) prosthetic socket (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio Willow Wood
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting	9; 8.7	>0.4
SECONDARY Participant Socket Preference After Initial Fitting	2; 0; 8	—
SECONDARY Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket	2; 4; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Be a lower extremity amputee longer than one year
Be a consenting adult (at least 18 years or age or older)
Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
Currently using a liner with prosthesis
Be available during regular business hours for appointments

Exclusion Criteria

An inability to give informed consent
Presence of any sores, lacerations or rashes on the residual limb
Impaired contra lateral foot
Poor distal sensation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01155024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.