Trial Outcomes & Findings for Digital Weight Bearing Shape Capture Socket Technology (NCT NCT05749952)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	SoC (Socket A) First, Then Symphonie Aqua System - Non-Digital (Socket B) Symphonie Aqua Digital System: A non-digital weight-bearing socket 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. Soc Socket is a standard of care socket fabricated under non weight nearing position. The two groups are combined because all subjects started with SoC and then crossed over to Socket B.
Standard of Care Socket STARTED	10
Standard of Care Socket COMPLETED	10
Standard of Care Socket NOT COMPLETED	0
Symphonie Aqua System - Non-Digital STARTED	10
Symphonie Aqua System - Non-Digital COMPLETED	8
Symphonie Aqua System - Non-Digital NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SoC (Socket A) First, Then Symphonie Aqua System - Non-Digital (Socket B) Symphonie Aqua Digital System: A non-digital weight-bearing socket 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. Soc Socket is a standard of care socket fabricated under non weight nearing position. The two groups are combined because all subjects started with SoC and then crossed over to Socket B.
Symphonie Aqua System - Non-Digital Lost to Follow-up	2

Baseline Characteristics

Digital Weight Bearing Shape Capture Socket Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symphonie Aqua System - Non-Digital (Socket B) n=10 Participants Socket shape capturing done under full weight bearing conditions, this is the test socket.
Age, Continuous	54 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Good quality TEWL data was available from n=5 in SoC and n=3 in DWB participants

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.

Outcome measures

Outcome measures
Measure	Socket A - Standard of Care Socket n=5 Participants SoC Socket is a standard of care socket fabricated under non-weight-bearing position.	Socket B - Symphonie Aqua Digital System n=3 Participants Symphonie Aqua Digital System: 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 will be temporarily used, whereas the final socket is for long-term use.
Trans-Epidermal Water Loss (TEWL)	22.9 g x m^-2xh^-1 Standard Deviation 9.46	14.7 g x m^-2xh^-1 Standard Deviation 5.11

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Socket A - Standard of Care Socket n=7 Participants SoC Socket is a standard of care socket fabricated under non-weight-bearing position.	Socket B - Symphonie Aqua Digital System n=7 Participants Symphonie Aqua Digital System: 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 will be temporarily used, whereas the final socket is for long-term use.
Laser Speckle Imaging (LSI)	4.8 PU Standard Deviation 3.4	4.1 PU Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Socket A - Standard of Care Socket n=8 Participants SoC Socket is a standard of care socket fabricated under non-weight-bearing position.	Socket B - Symphonie Aqua Digital System n=8 Participants Symphonie Aqua Digital System: 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 will be temporarily used, whereas the final socket is for long-term use.
In-socket Pressure	1.93 kPa Standard Deviation 1.36	0.91 kPa Standard Deviation 0.79

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Socket A - Standard of Care Socket n=8 Participants SoC Socket is a standard of care socket fabricated under non-weight-bearing position.	Socket B - Symphonie Aqua Digital System n=8 Participants Symphonie Aqua Digital System: 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 will be temporarily used, whereas the final socket is for long-term use.
Mobility (6MWT)	376 meters Standard Deviation 57	364 meters Standard Deviation 47

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Socket A - Standard of Care Socket n=8 Participants SoC Socket is a standard of care socket fabricated under non-weight-bearing position.	Socket B - Symphonie Aqua Digital System n=8 Participants Symphonie Aqua Digital System: 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 will be temporarily used, whereas the final socket is for long-term use.
Balance During Ambulation (TUG)	9.3 Seconds Standard Deviation 2.3	9.6 Seconds Standard Deviation 2.0

Adverse Events

Socket A - Standard of Care Socket

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Socket B - Symphonie Aqua Digital System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sashwati Roy

University of Pittsburgh

Phone: 412 624 0422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place