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Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees

NCT03164356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-05-03

Study results available
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Summary

The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis.

Conditions

  • Transtibial Amputee

Interventions

DEVICE

Bioimpedance monitor

Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort.

Sponsors & Collaborators

Principal Investigators

  • Joan E Sanders, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-09
Primary Completion
2020-09-14
Completion
2020-12-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03164356 on ClinicalTrials.gov