Peripheral Artery DiseasePhase 2/3NCT02034539
VADOplex Critical Limb Ischemia Study
A Phase 2/3 study testing VADOplex system in people with Peripheral Artery Disease and Quality of Life, run by Asklepios Kliniken Hamburg GmbH at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Quality of Life, Wound Healing
- What is being tested?
- VADOplex system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Nov 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Claas Lüdemann, MD contact
Germany1 site, 1 recruiting
- Recruiting
Gefäßzentrum, Asklepios Westklinikum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 22559
Claas Luedemann, MD, +49 (0) 40 8191-2019
Claas Luedemann, MD
About this 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
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.
- Conditions
- Peripheral Artery Disease, Quality of Life, Wound Healing
- Being tested
- VADOplex system
- Keywords
- peripheral artery disease, critical limb ischemia, VADOplex, intermittent foot compression
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VADOplex systemDevice
intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: VADOplex system |
| conservative treatment | No intervention | best medical treatment of the target lesion alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
complete healing of the target lesion
Measured: 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)
Measured: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Secondary outcomes (5)
time to complete wound healing
time until complete wound healing of the target lesion is achieved
Measured: 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
Measured: 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
Measured: 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
Measured: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
incidence of deep vein thrombosis
Measured: 24 weeks after discharge or whenever a thrombosis is suspected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios Kliniken Hamburg GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- OPED GmbH
- Responsible party
- Principal investigator, Claas Luedemann, Asklepios Kliniken Hamburg GmbH
- Investigators
- Holger Lawall, MD, Principal investigator, head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034539
- Sponsor's protocol ID
- VADOplex-1
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02034539
- Acronym / sponsor ID
- VADOplex-1
- Conditions
- Peripheral Artery Disease, Quality of Life, Wound Healing
- Keywords
- peripheral artery disease, critical limb ischemia, VADOplex, intermittent foot compression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Asklepios Kliniken Hamburg GmbHUniversity, hospital or other
- Collaborators
- OPED GmbH
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VADOplex treatment | Experimental | Device: VADOplex systembest 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VADOplex systemintermittent automatic pneumatic compression of the sole of the foot by the VADOplex system | Device | VADOplex treatment |
Primary outcome
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)
5 secondary outcomes
time to complete wound healing
Time frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Wound size
Time frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
change of pain intensity
Time frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
change of ankle-brachial index
Time frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
incidence of deep vein thrombosis
Time frame: 24 weeks after discharge or whenever a thrombosis is suspected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claas Lüdemann, MD contact
Holger Lawall, MD principal investigator
head of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VADOplex system in people with Peripheral Artery Disease and Quality of Life, run by Asklepios Kliniken Hamburg GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claas Lüdemann, MD (+49 (0) 40 8191-2019), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.