N/A
N=12
Socket Cooling Effectiveness Take Home Study
Amputation · Amputation; Traumatic, Leg, Lower · Amputation Stump · Limb; Absence, Congenital, Lower · Prosthesis User
Bottom Line
View on ClinicalTrials.gov: NCT04484805 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Residual Limb Temperature — -2.3; 1.9 Avg Temp Diff from Baseline (Degrees C)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ICE Condition (Device); Sham Condition (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Liberating Technologies, Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Limb Temperature |
-2.3; 1.9 | — |
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 materials that can create a warm and ultimately moist environment.
To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04484805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.