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| Name | Class |
|---|---|
| OPED GmbH | UNKNOWN |
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In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important goal which can normally only be achieved after sufficient treatment of the underlying ischemia (revascularization either by an operation, e. g. bypass, or a catheter intervention). After successful revascularization everything should be done to improve wound healing because this regularly takes weeks up to several months. One possibility to speed up healing could be treatment with the VADOplex device which delivers an automatic intermittent painless compression of the sole of the foot thereby increasing perfusion of the leg. This system can be easily operated by patients themselves and at home.
Our goal is to prove that the VADOPlex system accelerates healing up and improves quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VADOplex treatment | Experimental | best medical treatment in combination with intermittent pneumatic foot compression by the VADOplex system for 4 - 6 hours/day until total wound closure of the target lesion is achieved with a maximum treatment of 24 weeks |
|
| conservative treatment | No Intervention | best medical treatment of the target lesion alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VADOplex system | Device | intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system |
|
| Measure | Description | Time Frame |
|---|---|---|
| wound healing | complete healing of the target lesion | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge |
| change of quality of life | change of quality of life compared to baseline. Quality of life measured with the EQ-5D tool (European quality of life in 5 dimensions) | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| time to complete wound healing | time until complete wound healing of the target lesion is achieved | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge |
| Wound size | overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claas Lüdemann, MD | Contact | +49 (0) 40 8191-2019 |
| Name | Affiliation | Role |
|---|---|---|
| Holger Lawall, MD | head of department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gefäßzentrum, Asklepios Westklinikum Hamburg | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 22559 | Germany |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge |
| change of pain intensity | change of pain intensity compared to baseline. Pain intensity measured with a numeric rating scale (0 - 10) or if not applicable with a visual analogue scale | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge |
| change of ankle-brachial index | change of ankle-brachial index compared to basleline | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge |
| incidence of deep vein thrombosis | 24 weeks after discharge or whenever a thrombosis is suspected |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |