N/A
N=2
Moisture Management Liner Effectiveness Study
Amputation Stumps · Amputees · Amputation · Lower Limb Deformities, Congenital · Prosthesis User
Bottom Line
View on ClinicalTrials.gov: NCT04427007 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Residual Limb Temperature — 3.0; 3.2 Degrees Fahrenheit
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Moisture Management Liner (Device); Control Liner (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Liberating Technologies, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Limb Temperature |
3.0; 3.2 | — |
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.
The investigators have developed a silicone liner approach to remove sweat from the skin and out of the socket and to passively conduct heat from the skin using thermally conductive elastomers. This liner has been developed to work alongside a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE) developed in a parallel project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE device 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
- Lower limb amputee
- Be willing and able to complete the tasks outlined
- Are at least 6 months on a definitive prosthesis
- Fits within an experimental liner
- Can understand English in order to be properly consented and provide their 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
- Other unforeseen disqualifying criteria (such as specific cognitive issues, etc.)
Data sourced from ClinicalTrials.gov (NCT04427007). 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.