N/A
N=10
Digital Weight Bearing Shape Capture Socket Technology
Amputation · Prosthesis User · Residual Limbs
Bottom Line
View on ClinicalTrials.gov: NCT05749952 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Trans-Epidermal Water Loss (TEWL) — 22.9; 14.7 g x m^-2xh^-1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Symphonie Aqua Digital System mediated sh (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trans-Epidermal Water Loss (TEWL) |
22.9; 14.7 | — |
| SECONDARY Laser Speckle Imaging (LSI) |
4.8; 4.1 | — |
| SECONDARY In-socket Pressure |
1.93; 0.91 | — |
| SECONDARY Mobility (6MWT) |
376; 364 | — |
| SECONDARY Balance During Ambulation (TUG) |
9.3; 9.6 | — |
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.
Eligibility Criteria
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 280 lbs
Data sourced from ClinicalTrials.gov (NCT05749952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.