VADOplex Critical Limb Ischemia Study

NCT02034539 | Unknown Phase 2

• 1 other identifier: VADOplex-1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• wound healing

  complete healing of the target lesion

  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)

  at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge

Secondary Outcomes (5)

• time to complete wound healing

  at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge

• Wound size

  at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge

• change of pain intensity

  at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge

• change of ankle-brachial index

  at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge

• incidence of deep vein thrombosis

  24 weeks after discharge or whenever a thrombosis is suspected

Study Arms (2)

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

Device: VADOplex system

conservative treatment

NO INTERVENTION

best medical treatment of the target lesion alone

Interventions

VADOplex system DEVICE

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

VADOplex treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asklepios Kliniken Hamburg GmbH: lead
• OPED GmbH: collaborator

Study Sites (1)

Gefäßzentrum, Asklepios Westklinikum Hamburg

Hamburg, Hamburg, 22559, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Holger Lawall, MD

  head of department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claas Lüdemann, MD

CONTACT

+49 (0) 40 8191-2019

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Claas Luedemann, MD

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 13, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

DE (1)