NCT03199222|Unknown
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Sponsor study identifier
interventional
60
1 country
1
Study Start
March 29, 2018
Actual (reported)Primary Completion
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2017
Actual (reported)June 26, 2017
Actual (reported)March 29, 2018
Actual (reported)May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Intermediate stage prosthetic complications
Clinical documentation will track incidence of dermatologic issues, skin breakdown, sock ply, circumference, infection and wound severity.
Will be tracked for 120 days.
Limb volume activity of the residual limb
Limb volume will be tracked through clinical documentation including residual limb volumetrics (circumferential measurements), sock-ply changes (journal), and required interface changes will be used to record volume activity and corresponding consequence and management strategies.
Will be tracked for 120 days
Intermediate stage prosthetic complications (clinical documentation)
Re-hospitalization rate
Will be tracked for 120 days
Intermediate stage prosthetic complications (clinical documentation)
Revision rate will be documented
Will be tracked for 120 days
Balance and Stability
30 days post-amputation and at end of trial (120 days)
Mobility
30 days post-amputation and at end of trial (120 days)
Step Activity
120 days
Step Activity
120 days
The prosthetic user WILL receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). Investigators will have access to the Smart Socket Technology database.
The prosthetic user WILL NOT receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). However, investigators will have access to the Smart Socket Technology database.
The smart socket technology will send feedback to the user's smartphone with suggestions including the removal or application of prosthetic socks over the residual limb or other volume management strategies to improve fit and comfort.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of South Florida
Tampa, Florida, 33612, United States
Jason Highsmith, PhD
University of South Florida
First Submitted
April 4, 2017
First Posted
June 26, 2017
Study Start
March 29, 2018
Actual (reported)Primary Completion
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
July 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 20, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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