Skip to main content
OpenTrials
Completed

NCT Number: NCT05749952

Digital Weight Bearing Shape Capture Socket Technology

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amputation Prosthesis User Residual Limbs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

About this study

This study will compare the use of Symphonie Aqua Digital System, which is a new way to create a socket for prosthetics, to the current method that is generally used to create sockets. The study will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC).

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18 and above
  • Unilateral trans-tibial amputees
  • Ambulate at a K3 level or higher
  • At least 3 months post-amputation per physician discretion
  • Trans-tibial limb length greater than 4.5 inches in length
  • Able to follow directions and independently give informed consent
  • Must be able to ambulate without assistance

Exclusion criteria

  • Age < 18 years
  • Conditions that prevent wearing a prosthetic socket
  • Soc Socket made with weight bearing system
  • Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
  • Women who are pregnant or who plan to become pregnant in the near future
  • Weight > 280 lbs

Treatment and study plan

Symphonie Aqua Digital System mediated sh

Device

For socket fabrication, the shape capturing is done in full weight bearing.

Primary outcomes

  1. Trans-Epidermal Water Loss (TEWL)

    Time frame: 6 weeks

    Differences between two systems and effects on Trans-Epidermal Water Loss (TEWL) will be measured by placing a non-invasive probe on the surface of the skin. Each measurement takes approximately 7-30 seconds each. The data is presented as g x m^-2xh^-1. Higher number indicates worse outcome.

Secondary outcomes

  1. Laser Speckle Imaging (LSI)

    Time frame: 6-weeks

    Differences between two systems and effects on blood flow will be measured using Laser Speckle Imaging (LSI) which is a non-invasive machine that uses light to capture the blood flow of participants residual limb. The blood flow (perfusion) data is expressed as perfusion units (PU) where PU is a relative, dimensionless measure of tissue blood flow or microvascular perfusion. Higher value indicates better perfusion (increase in blood flow).

  2. In-socket Pressure

    Time frame: 6-weeks

    Measurements of socket pressure will be evaluated using in-socket sensors, which are positioned into the socket and function to detect the amount of residual load (pressure) that is placed on the limb.

  3. Mobility (6MWT)

    Time frame: 6-weeks

    6-minute walking test (6MWT); Subject will walk for 6 consecutive minutes and, once the 6 minutes has elapsed, the distance covered will be measured.

  4. Balance During Ambulation (TUG)

    Time frame: 6-weeks

    Timed up and go test; In the timed up-and-go outcome, the patient rises from a seated position, walks three meters at a self-selected speed, turns around, and returns to the chair where they reseat themselves.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Digital Weight Bearing Shape Capture Socket Technology to Preserve Limb Health and Improve Rehabilitation Outcomes

Acronym: DWB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.