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Socket Cooling Effectiveness Take Home Study

NCT04484805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-22

Study results available
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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.

Conditions

  • Amputation
  • Amputation; Traumatic, Leg, Lower
  • Amputation Stump
  • Limb; Absence, Congenital, Lower
  • Prosthesis User
  • Lower Limb Amputation Below Knee (Injury)

Interventions

DEVICE

ICE Condition

Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.

DEVICE

Sham Condition

Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.

Sponsors & Collaborators

  • Vivonics, Inc.

    collaborator INDUSTRY

  • Liberating Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-11-03
Completion
2020-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484805 on ClinicalTrials.gov