To determine the effect of IVT on walking distance after 6 and 12 weeks, 6 months and 1 year in patients with IC who are treated with a SET program. To determine the optimal timing for IVT within the SET program.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximum walking distance after 6 and 12 weeks, 6 months and 1 year, measured by
a standardized treadmill test .
Secondary outcome
Functional walking distance after 6 and 12 weeks, 6 months and 1 year, measured
by a standardized treadmill test .
Quality of life and walking disability after 6 and 12 weeks, 6 months and 1
year, measured by questionnaires.
Background summary
The preferred treatment for patients with intermittent claudication (IC) is
supervised exercise therapy (SET) supported with secondary risk prevention.
Today, patients with IC are also treated with intermittent vacuum therapy
(IVT). There is no hard evidence supporting the proposed mechanisms of action.
If we demonstrate that IVT influences the blood flow restricted by
atherosclerosis, it could potentially be an additional treatment for patients
with IC.
Study objective
To determine the effect of IVT on walking distance after 6 and 12 weeks, 6
months and 1 year in patients with IC who are treated with a SET program. To
determine the optimal timing for IVT within the SET program.
Study design
Randomized, placebo-controlled clinical pilot study of one year in the
Catharina Hospital in Eindhoven, the Maxima Medical Center Veldhoven and the
St. Anna Hospital in Geldrop.
Intervention
80 patients divided into 2 groups of 40 patients. Group 1: patients receive a
SET program during 1 year supplemented with IVT in weeks 1 till 12. Group 2:
patients receive a SET program during 1 year supplemented with sham-IVT in
weeks 1 till 12.
Study burden and risks
Patients receive standard conservative management for IC (CVRM and SET) and are
also referred to the 'Been-Kliniek' in Eindhoven for IVT or sham-IVT. There is
a minimum of 8 and a maximum of 12 IVT or sham-IVT treatments per patient. An
IVT or sham-IVT treatment takes 30 minutes. The total time investment per
patient is about 6 hours spread over 6 weeks, excluding travel time. There are
no risks associated with IVT or sham-IVT.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
• Conservative treatment with supervised exercise therapy (SET)
• Sufficient additional insurance or sufficient financial resources for a SET program of 1 year
• Sufficiently motivated to participate in the study (particularly additional (travel) time investment for treatment with IVT in the 'Been-Kliniek' in Eindhoven)
• Informed consent
Exclusion criteria
• Previous treatment for PAD in the past 2 years (conservative and/or invasive technique)
• Prior treatment with IVT (possibly for other indications than PAD)
• Cognitive disabilities
• Inadequate control of the Dutch language
• Contraindications for IVT (pregnancy, infection and/or inflammation of the lower limb(s), abdominal wall hernia)
• Recent (<6 weeks) trauma of the lower limb(s)
• Severe cox- or gonarthrosis and planned joint replacement therapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54340.100.15 |
| OMON | NL-OMON26769 |