VADOplex Critical Limb Ischemia Study

• ClinicalTrials.gov Identifier: NCT02034539
• Recruitment Status: Unknown
• First Posted: January 13, 2014
• Last Update Posted: January 13, 2014
• Sponsor: Asklepios Kliniken Hamburg GmbH
• Collaborator: OPED GmbH
• Information provided by (Responsible Party): Claas Luedemann, Asklepios Kliniken Hamburg GmbH

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Artery Disease; Quality of Life; Wound Healing	Device: VADOplex system	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospektive, Randomisierte Und Kontrollierte Studie Zum Einfluss Des VADOplex-Systems Auf Die Lebensqualität im Rahmen Der Behandlung Der Chronisch-kritischen Extremitätenischämie im Stadium IV Nach Fontaine
• Study Start Date: October 2013
• Estimated Primary Completion Date: October 2014
• Estimated Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: VADOplex treatment; 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	Device: VADOplex system; intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system
No Intervention: conservative treatment; best medical treatment of the target lesion alone

Outcome Measures

Primary Outcome Measures :

1. wound healing [ Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge ]
   complete healing of the target lesion
2. change of quality of life [ Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge ]
   change of quality of life compared to baseline. Quality of life measured with the EQ-5D tool (European quality of life in 5 dimensions)

Secondary Outcome Measures :

1. time to complete wound healing [ Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge ]
   time until complete wound healing of the target lesion is achieved
2. Wound size [ Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge ]
   overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline
3. change of pain intensity [ Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge ]
   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
4. change of ankle-brachial index [ Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge ]
   change of ankle-brachial index compared to basleline
5. incidence of deep vein thrombosis [ Time Frame: 24 weeks after discharge or whenever a thrombosis is suspected ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• signed informend consent
• peripheral artery disease Fontaine IV (equals Ruterford 5 and 6) with or without neuropathy
• foot lesion stage 1 - 4 analogous to 4 Wagner classification of the diabetic foot
• secondary wound healing if previous surgical wound treatment
• previous interventional and/or surgical revascularisation
• age above 18
• hosptalized to the beginning of the study

Exclusion Criteria:

• primary wound healing if previous surgical wound treatment
• uncontrolled local or systemic infection
• renal failure on dialysis
• inability or insufficient help to operate the VADOplex system
• wound dressings that lead to insufficient compression by the VADOplex system (e.g. total contact cast for offloading)
• wounds of other than ischemic or neuro-ischemic origin

Contacts and Locations

Contacts

Contact: Claas Lüdemann, MD; +49 (0) 40 8191-2019

Locations

Germany

Gefäßzentrum, Asklepios Westklinikum Hamburg; Recruiting

Hamburg, Germany, 22559

Contact: Claas Luedemann, MD +49 (0) 40 8191-2019

Sub-Investigator: Claas Luedemann, MD

Sponsors and Collaborators

Asklepios Kliniken Hamburg GmbH

OPED GmbH

Investigators

• Principal Investigator: Holger Lawall, MD; head of department

More Information

• Responsible Party: Claas Luedemann, Claas Luedemann, MD, Asklepios Kliniken Hamburg GmbH
• ClinicalTrials.gov Identifier: NCT02034539
• Other Study ID Numbers: VADOplex-1
• First Posted: January 13, 2014
• Last Update Posted: January 13, 2014
• Last Verified: January 2014

Keywords provided by Claas Luedemann, Asklepios Kliniken Hamburg GmbH:

peripheral artery disease; critical limb ischemia; VADOplex; intermittent foot compression

Additional relevant MeSH terms:

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases