Critical limb ischemia: primary or secondary amputation versus intervention (bypass or PTA), impact at functional outcome.

Critical limb ischemia: primary or secondary amputation versus intervention (bypass or PTA), impact at functional outcome. - PRINT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31138

Enrollment

200

Registered

2007-07-12

Start date

2007-06-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

critical vascular disease Fontaine 3 & 4

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Critical limb ischemia requiring therapy consisting of either a bypass or PTA or major lower limb amputation (below, through, above knee). Age 18 years or older.

Exclusion criteria

Exclusion criteria: Unable to fill-in self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc). Life-expectancy less than 3 months. Legally incompetent adults.

Design outcomes

Primary

Measure	Time frame
The main endpoint is the functional ability and QoL of patients 6 months and one year after intervention (lower limb amputation or revascularization procedure).	—

Secondary

Measure	Time frame
Secondary endpoint is the assessment in terms of physiological and mobility parameters.	—

Countries

Netherlands

Outcome results