VADOplex Critical Limb Ischemia Study

NCT ID: NCT02034539

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-11-30

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.

Conditions

Peripheral Artery Disease; Quality of Life; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

VADOplex system

Intervention Type: DEVICE

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

conservative treatment

best medical treatment of the target lesion alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VADOplex system

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OPED GmbH

UNKNOWN

Sponsor Role: collaborator

Asklepios Kliniken Hamburg GmbH

OTHER

Sponsor Role: lead

Responsible Party

Claas Luedemann

Claas Luedemann, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holger Lawall, MD

Role: PRINCIPAL_INVESTIGATOR

head of department

Locations

Gefäßzentrum, Asklepios Westklinikum Hamburg

Hamburg, City state of Hamburg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claas Lüdemann, MD

Role: CONTACT

+49 (0) 40 8191-2019

Facility Contacts

Claas Luedemann, MD

Role: primary

+49 (0) 40 8191-2019

Other Identifiers

VADOplex-1

Identifier Type: -

Identifier Source: org_study_id