Open Label Clinical Study to Assess the Clinical Safety of a New Compression Device in Subjects With Peripheral Arterial Vascular Disease
|Peripheral Arterial Vascular Disease||Procedure: A new treatment approach is to have an effective working pressure combined with a low resting pressure.|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open Label Clinical Study to Assess the Clinical Safety of a New Compression Procedure in Subjects With Peripheral Arterial Vascular Disease|
- 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. [ Time Frame: 2 weeks ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854516
|Greifswald, Germany, 17487|
|Principal Investigator:||Michael Juenger, Prof. Dr. MD||Universitaetsklinikum Greifswald|