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Not Yet Recruiting
NCT05749952
Digital Weight Bearing Shape Capture Socket Technology
Conditions: Amputation, Prosthesis User, Residual Limbs
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 12
Sponsor: Indiana University
Location: United States
Summary
We hope to find out if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability outcomes than traditional sockets.
Additionally, we want to see if a well-fitting socket will positively impact the overall health of your residual limb.
Eligibility Criteria
Inclusion Criteria:Ages 18 and aboveUnilateral trans-tibial amputeesAmbulate at a K3 level or higherAt least 3 months post-amputation per physician discretionTrans-tibial limb length greater than 4.5 inches in lengthAble to follow directions and independently give informed consentMust be able to ambulate without assistanceExclusion Criteria:Age < 18 yearsConditions that prevent wearing a prosthetic socketSoc Socket made with weight bearing systemCognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocolWomen who are pregnant or who plan to become pregnant in the near futureWeight > 280 lbs
Source: ClinicalTrials.gov (NCT05749952). StuddyBuddy aggregates publicly available trial information.