Digital Weight Bearing Shape Capture Socket Technology

NCT05749952 | Completed Results DMC FDA Device

• 1 other identifier: 15478
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation; Prosthesis User; Residual Limbs

Outcome Measures

Primary Outcomes (1)

• Trans-Epidermal Water Loss (TEWL)

  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.

  6 weeks

Secondary Outcomes (4)

• Laser Speckle Imaging (LSI)

  6-weeks

• In-socket Pressure

  6-weeks

• Mobility (6MWT)

  6-weeks

• Balance During Ambulation (TUG)

  6-weeks

Study Arms (2)

Symphonie Aqua System - Non-Digital (Socket B)

EXPERIMENTAL

A digital weight bearing test socket where shape capturing is done in full weight bearing

Device: Symphonie Aqua Digital System mediated sh

Standard of Care (SoC)

ACTIVE COMPARATOR

This is standard of care socket design where sockets are fabricated in non-weight bearing position

Device: Symphonie Aqua Digital System mediated sh

Interventions

Symphonie Aqua Digital System mediated sh DEVICE

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

Standard of Care (SoC); Symphonie Aqua System - Non-Digital (Socket B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Sashwati Roy
• Organization: University of Pittsburgh

sasr453@pitt.edu

412 624 0422

Study Officials

• Sashwati Roy, PhD.

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: This is a crossover study where participants perform baseline visit in standard of care and then switched to DWB arm.

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: March 6, 2023
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Locations

US (1)