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Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration

NCT07024342 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-01-09

No results posted yet for this study

Summary

The specific aim of this research is to compare three clinically available liners, each intended to address problems of residual limb perspiration, with the as-prescribed liner of lower limb prosthesis user and determine their effect on stability, suspension, and comfort.

Conditions

  • Amputation
  • Prosthesis User

Interventions

DEVICE

Liner perforated with very small diameter holes

A commercially available, elastomeric liner perforated with very small holes (approximately 0.3 mm diameter) to allow perspiration to drain. This liner is worn between the skin and the participant's prosthetic socket.

DEVICE

Liner perforated with somewhat larger diameter holes

A commercially available, elastomeric liner perforated with somewhat larger holes (approximately 1.5 mm diameter) to allow perspiration to drain. This liner is worn between the skin and the participant's prosthetic socket.

DEVICE

Liner-liner

A thin, special purpose half-ply sock which may reduce the effects of perspiration. The liner-liner is worn between the skin and the participant's as-prescribed liner.

DEVICE

As-prescribed liner

A commercially available, elastomeric liner with no perforations. This liner is worn between the skin and the participant's prosthetic socket.

Sponsors & Collaborators

  • VA Puget Sound Health Care System

    lead FED

Principal Investigators

  • Glenn K Klute, PhD · US Department of Veterans Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2026-02-28
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07024342 on ClinicalTrials.gov