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N/A Completed N=2 Randomized Other

Moisture Management Liner Effectiveness Study

Amputation Stumps · Amputees · Amputation · Lower Limb Deformities, Congenital
Source: ClinicalTrials.gov NCT04427007 ↗
Enrolled (actual)
2
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Residual Limb Temperature — 3.0; 3.2 Degrees Fahrenheit

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Residual Limb Temperature
3.0; 3.2

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.)
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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