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Open Label Clinical Study to Assess the Clinical Safety of a New Compression Device in Subjects With Peripheral Arterial Vascular Disease

NCT00854516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-02

No results posted yet for this study

Summary

To assess the safety of a new compression device applied to patients with an ankle brachial pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice. Several perfusion assessments will investigate safety under reduced compression therapy.

Conditions

  • Peripheral Arterial Vascular Disease

Interventions

PROCEDURE

A new treatment approach is to have an effective working pressure combined with a low resting pressure.

Procedure Schedule: The total duration for study participation will be 14 days (8 visits). Subject eligibility will be determined at the initiation visit. All eligible subjects will receive the compression device on the study leg and will return to the clinical center at day 1, 2, 3, 4, 7, 10 and 14 to assess safety. At each clinical visit (except visit day 14) the compression device will be reapplied. The study participation ends after 14 days.

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Michael Juenger, Prof. Dr. MD · Universitaetsklinikum Greifswald

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-10-31
Completion
2010-01-31

Countries

  • Germany

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 NCT00854516 on ClinicalTrials.gov