I70.2
Conditions
Interventions
Group 1: VADOplex application for at least 4 hours per day and at least one hour duration at a single time point combined with independent walking training (standard of care therapy (SOC)) as recommen
Sponsors
Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Adequate general condition, clinical stability (not frail, without pronounced overweight or underweight) - Sufficient cognitive function and compliance - Sufficient mobility in the home environment - Ability to participate at the control visits or to be transported to preliminary and follow-up visits. - Best medical treatment under stable conditions for at least three months before study inclusion.
Exclusion criteria
Exclusion criteria: - Manifested venous or lymphatic edema - Surgical revascularization or other interventions within the last 3 months, - Planned surgical revascularization during the intervention period (6 months) - Existing wounds at the lower extremities - New RAS acting agents during participation in the registry trial - Post-stroke condition with residual cognitive, sensory or motor deficits, cerebrovascular events (hemorrhage, TIA, stroke, embolism <30d) - Neurological/ neuromuscular underlying diseases (e.g. Parkinson's disease) - Underlying psychiatric illnesses (dementia or other cognitive impairments) - Mobility-limiting orthopedic or other diseases - Cardiovascular diseases including decompensated heart failure, severe aortic valve stenosis and other severe end-stage cardiovascular disease - Cancer with metastatic cancer or life expectance less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the superiority of a combined treatment of walking training as the SOC with additional 6 months ambulant VADOplex application in comparison to the SOC with independent walking training alone regarding improvement of walking distance (? of initial walking distance (ICD and ACD)) in relation to walking distance after 6 months of intervention in the intervention group or after 6 months SOC treatment in the control group of LEAD patients (stage 1-3). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the impact on Quality of life of patients with LEAD with additional VADOplex application compared to home-based exercise training alone - To evaluate the resting ankle-brachial index (ABI) between the two groups - To evaluate the compliance to VADOplex application - To evaluate the compliance to self walking training - To assess device related events, hospitalization, survival status | — |
Countries
Germany
Contacts
Public ContactChristine Espinola-Klein
Universitätsmedizin Mainz
Outcome results
None listed