Status:
COMPLETED
Open Label Clinical Study to Assess the Clinical Safety of a New Compression Device in Subjects With Peripheral Arterial Vascular Disease
Lead Sponsor:
Solventum US LLC
Collaborating Sponsors:
3M
Conditions:
Peripheral Arterial Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
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...
Eligibility Criteria
Inclusion
- Males or females, age 18 years or older.
- 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.
- Subjects who are co-operative, willing to give written informed consent prior to study entry and willing to comply with the study protocol.
- Subjects who can walk (with or without a walking aid).
- \-
Exclusion
- Subjects with an ABPI \< 0.5 or \> 0.8 as measured within up to 4 weeks prior to enrollment.
- Subjects whose general condition, in the opinion of the investigator, preclude for compression therapy.
- Subjects with paralysis of the study leg
- Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
- Subjects with significant instable coagulopathy; subjects treated with anticoagulant therapeutics can be included.
- Subjects who are participating in any prospective clinical study that can potentially interfere with this study.
- Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria.
- Subjects with known allergies to other materials in the compression device.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00854516
Start Date
February 1 2009
End Date
January 1 2010
Last Update
October 2 2024
Active Locations (1)
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1
Universitaetsklinikum Greifswald
Greifswald, Germany, 17487