Status:
COMPLETED
Socket Cooling Effectiveness Take Home Study
Lead Sponsor:
Liberating Technologies, Inc.
Collaborating Sponsors:
Vivonics, Inc.
Conditions:
Amputation
Amputation; Traumatic, Leg, Lower
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive mat...
Detailed Description
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive mat...
Eligibility Criteria
Inclusion
- Must have a lower limb absence
- Willing and able to complete outlined tasks
- Must complete and pass our Semmes-Weinstein monofilament test
- Must understand English in order to be properly consented and provide feedback to the study personnel
Exclusion
- The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study
- No symptoms consistent with peripheral neuropathy or other sensory diagnosis that could prevent them from feeling the temperature of their limb
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04484805
Start Date
August 1 2019
End Date
November 3 2020
Last Update
October 22 2024
Active Locations (2)
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1
Liberating Technologies, Inc.
Holliston, Massachusetts, United States, 01746
2
Minneapolis VA
Minneapolis, Minnesota, United States, 55417