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

Tracking Information

• First Submitted Date: January 10, 2014
• First Posted Date: January 13, 2014
• Last Update Posted Date: January 13, 2014
• Study Start Date: October 2013
• Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2014)

• 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
• 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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 10, 2014)

• 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
• 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
• 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
• 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
• incidence of deep vein thrombosis [ Time Frame: 24 weeks after discharge or whenever a thrombosis is suspected ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: VADOplex Critical Limb Ischemia Study
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Peripheral Artery Disease
• Quality of Life
• Wound Healing

Intervention

Device: VADOplex system

intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system

Study Arms

• 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
  Intervention: Device: VADOplex system
• No Intervention: conservative treatment
  best medical treatment of the target lesion alone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 10, 2014): 38
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2014
• Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02034539
• Other Study ID Numbers: VADOplex-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Claas Luedemann, Asklepios Kliniken Hamburg GmbH
• Study Sponsor: Asklepios Kliniken Hamburg GmbH
• Collaborators: OPED GmbH

Investigators

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

• PRS Account: Asklepios Kliniken Hamburg GmbH
• Verification Date: January 2014