VADOplex Critical Limb Ischemia Study

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02034539
• Other study ID #: VADOplex-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 10, 2014
• Last updated: January 10, 2014
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2014
• Source: Asklepios Kliniken Hamburg GmbH
• Contact: Claas Lüdemann, MD
• Phone: +49 (0) 40 8191-2019
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• 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

Locations

Country	Name	City	State
Germany	Gefäßzentrum, Asklepios Westklinikum Hamburg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Asklepios Kliniken Hamburg GmbH	OPED GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing	complete healing of the target lesion	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge	No
Primary	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	No
Secondary	time to complete wound healing	time until complete wound healing of the target lesion is achieved	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge	No
Secondary	Wound size	overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge	No
Secondary	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	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge	No
Secondary	change of ankle-brachial index	change of ankle-brachial index compared to basleline	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge	No
Secondary	incidence of deep vein thrombosis		24 weeks after discharge or whenever a thrombosis is suspected	No