An interventional study of E-Socket Monitoring in Trans-Tibial Amputation, sponsored by University of Washington. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by University of Washington · Not applicable, Interventional, and Other
The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).
Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.
Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Prosthesis Users:
Aims 1 and 2
Aim 2
-Regularly visit their prosthetist at least twice a year,
Exclusion Criteria:
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Prosthesis Users:
Aims 1 and 2
Aim 1 Only
-Vacuum suspension users
Other: E-Socket Monitoring
Limb-socket motion data is collected during participant take-home use. Bimonthly telephone interviews are conducted to assess participant residual limb health status. Analysis is conducted to determine if limb motions and activity changes precede limb health changes.
Anterior-Distal Limb Motion
Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.
Time frame: 12 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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