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Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit

NCT00117793 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-08-15

Study results available
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Summary

The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system.

The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.

Conditions

  • Amputation
  • Diabetes
  • Leg Injuries
  • Traumatic Amputations

Interventions

DEVICE

Total Surface Bearing Suction Socket

Current clinical practice

DEVICE

Vacuum assisted socket system

Novel socket system

Sponsors & Collaborators

Principal Investigators

  • Glenn K. Klute, PhD · VA Puget Sound Health Care System, Seattle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00117793 on ClinicalTrials.gov