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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Vascular Disease
• Intervention / Treatment: Procedure: A new treatment approach is to have an effective working pressure combined with a low resting pressure.

Detailed Description

Venous leg ulcers represent a very common clinical problem with increasing prevalence in an aging population. It is believed that venous insufficiency is the underlying condition responsible for 54-81% of leg ulcers. About 8% of leg ulcers are related to arterial insufficiency and about 14% have a mixed aetiology. Compression therapy is considered the most effective treatment for these ulcers. The overall cost of chronic venous leg ulcer is high because long term ongoing care is required. Also the quality of life of these patients is jeopardized due to long lasting ulcer treatments and inconvenient compression therapies.

Several compression products are available on the market and there is a large body of literature describing the clinical benefit of different compression systems.

A new treatment approach with the new device is to have an effective working pressure combined with a low resting pressure. A high working pressure achieved by a rigid sleeve around a patient's leg is essential to support the muscle pump, necessary for sufficient blood reflux. However the resting pressure could be low without relevant reduction of compression efficacy but with an increase in safety for patients with a mild to moderate peripheral arterial occlusive disease (PAOD). A high resting pressure is believed to be a main reason for reduced arterial skin perfusion which can result in pressure related skin damage. Accordingly most compression systems are not indicated for patients with an ABPI lower than 0.8. About 25% of patients with chronic venous insufficiency suffer from PAOD and hence are very difficult to treat with compression. With the new device, these patients could be sufficiently treated, because a low resting pressure is believed to have low influence on skin perfusion.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17487
    • Universitaetsklinikum Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females, age 18 years or older.
2. Subjects suffering from peripheral arterial occlusive disease (PAOD) with an ABPI (ankle brachial pressure index) of the treated leg between 0.5 - 0.8 as measured within up to 4 weeks prior to enrollment. About 5 subjects of the study population should have an ABPI of 0.5.
3. Subjects who are co-operative, willing to give written informed consent prior to study entry and willing to comply with the study protocol.

4. Subjects who can walk (with or without a walking aid).

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Exclusion Criteria:

1. Subjects with an ABPI < 0.5 or > 0.8 as measured within up to 4 weeks prior to enrollment.
2. Subjects whose general condition, in the opinion of the investigator, preclude for compression therapy.
3. Subjects with paralysis of the study leg
4. Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
5. Subjects with significant instable coagulopathy; subjects treated with anticoagulant therapeutics can be included.
6. Subjects who are participating in any prospective clinical study that can potentially interfere with this study.
7. Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria.
8. Subjects with known allergies to other materials in the compression device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this study is to assess the safety of the new compression device in subjects with an ankle brachial pressure index (ABPI) between 0.5-0.8.	2 weeks

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Michael Juenger, Prof. Dr. MD, Universitaetsklinikum Greifswald

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 27, 2009
• First Submitted That Met QC Criteria: March 2, 2009
• First Posted (Estimate): March 3, 2009

Study Record Updates

• Last Update Posted (Estimate): January 23, 2012
• Last Update Submitted That Met QC Criteria: January 20, 2012
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: compression therapy; 3M
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: EU Study No-05-000007