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VADOplex Critical Limb Ischemia Study

Primary Purpose

Peripheral Artery Disease, Quality of Life, Wound Healing

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
VADOplex system
Sponsored by
Asklepios Kliniken Hamburg GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring peripheral artery disease, critical limb ischemia, VADOplex, intermittent foot compression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gefäßzentrum, Asklepios Westklinikum HamburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VADOplex treatment

conservative treatment

Arm Description

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

best medical treatment of the target lesion alone

Outcomes

Primary Outcome Measures

wound healing
complete healing of the target lesion
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)

Secondary Outcome Measures

time to complete wound healing
time until complete wound healing of the target lesion is achieved
Wound size
overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline
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
change of ankle-brachial index
change of ankle-brachial index compared to basleline
incidence of deep vein thrombosis

Full Information

First Posted
January 10, 2014
Last Updated
January 10, 2014
Sponsor
Asklepios Kliniken Hamburg GmbH
Collaborators
OPED GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02034539
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asklepios Kliniken Hamburg GmbH
Collaborators
OPED GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Quality of Life, Wound Healing
Keywords
peripheral artery disease, critical limb ischemia, VADOplex, intermittent foot compression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VADOplex treatment
Arm Type
Experimental
Arm Description
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
Arm Title
conservative treatment
Arm Type
No Intervention
Arm Description
best medical treatment of the target lesion alone
Intervention Type
Device
Intervention Name(s)
VADOplex system
Intervention Description
intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system
Primary Outcome Measure Information:
Title
wound healing
Description
complete healing of the target lesion
Time Frame
at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Title
change of quality of life
Description
change of quality of life compared to baseline. Quality of life measured with the EQ-5D tool (European quality of life in 5 dimensions)
Time Frame
at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Secondary Outcome Measure Information:
Title
time to complete wound healing
Description
time until complete wound healing of the target lesion is achieved
Time Frame
at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Title
Wound size
Description
overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline
Time Frame
at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Title
change of pain intensity
Description
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
Time Frame
at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Title
change of ankle-brachial index
Description
change of ankle-brachial index compared to basleline
Time Frame
at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Title
incidence of deep vein thrombosis
Time Frame
24 weeks after discharge or whenever a thrombosis is suspected

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claas Lüdemann, MD
Phone
+49 (0) 40 8191-2019
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Lawall, MD
Organizational Affiliation
head of department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gefäßzentrum, Asklepios Westklinikum Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claas Luedemann, MD
Phone
+49 (0) 40 8191-2019
First Name & Middle Initial & Last Name & Degree
Claas Luedemann, MD

12. IPD Sharing Statement

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VADOplex Critical Limb Ischemia Study

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