E-Socket, Diagnostic Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: E-Socket Monitoring.
- Who it may be relevant to
- Registry conditions: Trans-Tibial Amputation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Anterior-Distal Limb Motion [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
\-
Prosthesis Users:
Aims 1 and 2
- Over 18 years of age
- Unilateral or bilateral trans-tibial amputation at least 12 months prior
- Have a limb of length 9 cm or greater
- Are capable of at least 5 minutes of continuous walking
- Regularly use a definitive prosthesis
- Do not regularly use assistive devices (e.g., cane, walker) for ambulation
- Do not have open wounds on their residual limb at the time of enrollment
Aim 2
-Regularly visit their prosthetist at least twice a year,
Exclusion criteria
\-
Prosthesis Users:
Aims 1 and 2
- Reduced skin sensation
- Presence of skin breakdown
- Regular use of an assistive device
- Persons with trans-femoral amputation
Aim 1 Only
-Vacuum suspension users
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06432335 · STUDY00016676