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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02034539
Other study ID # VADOplex-1
Secondary ID
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


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
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