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Procedure

Symphonie Aqua System - Non-Digital (Socket B) for Prosthesis User (DWB Trial)

N/A
Waitlist Available
Led By Sashwati Roy, PhD.
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Trans-tibial limb length greater than 4.5 inches in length
Unilateral trans-tibial amputees
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights

DWB Trial Summary

This trial tests a new method of socket creation to see if it can improve fit and comfort for amputees, and if that can help improve their overall health.

Eligible Conditions
  • Prosthesis User
  • Amputation
  • Prosthetic Limbs

DWB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your lower leg (below the knee) is longer than 4.5 inches.
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You have lost one leg below the knee.
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You can walk independently at a moderate to high level of ability.

DWB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Laser Speckle Imaging (LSI)
Trans-Epidermal Water Loss (TEWL)
Secondary outcome measures
Balance during ambulation (TUG)
Houghton Scale
In-socket pressure
+3 more

DWB Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Symphonie Aqua System - Non-Digital (Socket B)Experimental Treatment2 Interventions
We will digitally capture (via computer) the shape of your limb, which will create a digital file (computer file) of what the internal shape of your socket should be. This file will then be used with a computer software program to optimize the fit of your prosthesis. This image will be used to create a check socket (temporary socket) to confirm a correct anatomical and comfortable socket. Then the check socket (temporary socket) will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use.
Group II: Standard of Care - Non-Weight Bearing (Socket A)Active Control1 Intervention
A non-digital weight-bearing socket will be used to create the check socket (temporary socket), which will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Symphonie Aqua Digital System
2023
N/A
~10
Symphonie Aqua System (Non-Digital)
2023
N/A
~10

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
976 Previous Clinical Trials
983,367 Total Patients Enrolled
2 Trials studying Prosthesis User
26 Patients Enrolled for Prosthesis User
United States Department of DefenseFED
856 Previous Clinical Trials
225,585 Total Patients Enrolled
4 Trials studying Prosthesis User
330 Patients Enrolled for Prosthesis User
Sashwati Roy, PhD.Principal InvestigatorIndiana University
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Symphonie Aqua Digital System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05749952 — N/A
Prosthesis User Research Study Groups: Standard of Care - Non-Weight Bearing (Socket A), Symphonie Aqua System - Non-Digital (Socket B)
Prosthesis User Clinical Trial 2023: Symphonie Aqua Digital System Highlights & Side Effects. Trial Name: NCT05749952 — N/A
Symphonie Aqua Digital System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05749952 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research still recruiting participants?

"As per clinicaltrials.gov, this medical trial is not currently recruiting patients. Initially posted on March 6th 2023 and last updated in February of the same year, no further participants are needed for now; however, 71 other trials remain open to potential volunteers at present."

Answered by AI

What are the key goals of this experiment?

"The main aim of this 12-week analysis is to gauge Limb Health by assessing Trans-Epidermal Water Loss (TEWL) with an Instrument. Secondary objectives encompass Mobility, Balance while ambulating, and Prosthesis Evaluation Questionnaires - the Houghton Scale in particular - using a 4-item scoring system with nine or more indicating successful prosthetic rehabilitation. A 6-minute walking test will be employed as part of tracking patient Mobility. Additionally, for monitoring balance during movement, participants must complete a Timed up and go task which requires them to rise from their seat, cover three meters at their own pace then return"

Answered by AI
~5 spots leftby Mar 2025