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Pilot study added value intermittent vacuum therapy (IVT)

Pilot study added value intermittent vacuum therapy (IVT) - Pilot Vacumed

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44065
Enrollment
80
Registered
2015-12-01
Start date
2015-12-04
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intermittent claudication peripheral arterial disease

Interventions

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 yea

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

MeasureTime frame
Maximum walking distance after 6 and 12 weeks, 6 months and 1 year, measured by a standardized treadmill test .

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)