AmputationDWBNCT05749952
Digital Weight Bearing Shape Capture Socket Technology
A study testing Symphonie Aqua Digital System mediated sh in people with Amputation and Prosthesis User, run by Indiana University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Prosthesis User, Residual Limbs
- What is being tested?
- Symphonie Aqua Digital System mediated sh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Digital Weight Bearing Shape Capture Socket Technology to Preserve Limb Health and Improve Rehabilitation Outcomes
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.
Read the detailed description
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.
- Conditions
- Amputation, Prosthesis User, Residual Limbs
- Being tested
- Symphonie Aqua Digital System mediated sh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphonie Aqua Digital System mediated shDevice
For socket fabrication, the shape capturing is done in full weight bearing.
| Study group | Role | What they receive |
|---|---|---|
| Symphonie Aqua System - Non-Digital (Socket B) | Experimental | A digital weight bearing test socket where shape capturing is done in full weight bearing Receives: 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 Receives: Device: Symphonie Aqua Digital System mediated sh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
Laser Speckle Imaging (LSI)
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).
Measured: 6-weeks
In-socket Pressure
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.
Measured: 6-weeks
Mobility (6MWT)
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.
Measured: 6-weeks
Balance During Ambulation (TUG)
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.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start6 Mar 2023
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a crossover study where participants perform baseline visit in standard of care and then switched to DWB arm.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Dr. Sashwati Roy, Indiana University
- Investigators
- Sashwati Roy, PhD., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749952
- Sponsor's protocol ID
- 15478
- Acronym
- DWB
- Status last verified
- Oct 2025
- First submitted
- 19 Feb 2023
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Weight Bearing Shape Capture Socket Technology to Preserve Limb Health and Improve Rehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT05749952
- Acronym / sponsor ID
- DWB / 15478
- Conditions
- Amputation, Prosthesis User, Residual Limbs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Posted 31 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a crossover study where participants perform baseline visit in standard of care and then switched to DWB arm.
| Arm | Type | Receives |
|---|---|---|
| Symphonie Aqua System - Non-Digital (Socket B) | Experimental | Device: Symphonie Aqua Digital System mediated shA digital weight bearing test socket where shape capturing is done in full weight bearing |
| Standard of Care (SoC) | Active comparator | Device: Symphonie Aqua Digital System mediated shThis is standard of care socket design where sockets are fabricated in non-weight bearing position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symphonie Aqua Digital System mediated shFor socket fabrication, the shape capturing is done in full weight bearing. | Device | Standard of Care (SoC), Symphonie Aqua System - Non-Digital (Socket B) |
Primary outcome
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.
4 secondary outcomes
Laser Speckle Imaging (LSI)
Time frame: 6-weeks
In-socket Pressure
Time frame: 6-weeks
Mobility (6MWT)
Time frame: 6-weeks
Balance During Ambulation (TUG)
Time frame: 6-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Amputation
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Prosthetic Socket Fit Testing System
Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sashwati Roy, PhD. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symphonie Aqua Digital System mediated sh in people with Amputation and Prosthesis User, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trans-Epidermal Water Loss (TEWL) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.