Venous claudication treadmill trial

Venous claudication treadmill trial - VCT-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55978

Enrollment

Registered

2023-08-11

Start date

2023-09-07

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

Venous insufficiency. Venous claudication

Interventions

Patients will perform a treadmill exercise test. The treadmill test is standardized and will have pre-set of the speed (3.2km/h) and inclination of 0% at the beginning according to the protocol base

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Voluntary and mentally competent individuals from 18 years of age - Understanding of the Dutch language - Symptoms of venous claudication after a prior DVT with an indication for endovascular stenting. - Able to perform a treadmill exercise test. - Written informed consent

Exclusion criteria

Exclusion criteria: - Having any other morbidity that prevent patients from performing a walking test. - Having any other morbidity that mimics similar symptoms, most of all arterial claudication - Inability to give informed consent (cognitive impairments, no good understanding of the Dutch language) - Prior vascular intervention for an acute DVT (surgery, interventional catheter-directed thrombolytic therapy, stent) - Participating in other research projects that can influence outcomes of this study (such as venous interventions, physical exercise programs) - Pregnancy up to 2 months postpartum

Design outcomes

Primary

Measure	Time frame
o Distance in meters on a standardized treadmill test until patients develop known symptoms as tightness and/or pain: initial claudication distance (ICD). o Distance in meters on a standardized treadmill test until patients develop severe known symptoms as tightness and/or pain that compel them to stop walking: absolute claudication distance (ACD). o Time in minutes on a standardized treadmill test until patients develop known symptoms as tightness and/or pain: initial claudication time (ACT). o Time in minutes on a standardized treadmill test until patients develop severe known symptoms as tightness and/or pain that compel them to stop walking: absolute claudication time (ACT).	—

Measure

Time frame

o Distance in meters on a standardized treadmill test until patients develop known symptoms as tightness and/or pain: initial claudication distance (ICD). o Distance in meters on a standardized treadmill test until patients develop severe known symptoms as tightness and/or pain that compel them to stop walking: absolute claudication distance (ACD). o Time in minutes on a standardized treadmill test until patients develop known symptoms as tightness and/or pain: initial claudication time (ACT). o Time in minutes on a standardized treadmill test until patients develop severe known symptoms as tightness and/or pain that compel them to stop walking: absolute claudication time (ACT).

—

Secondary

Measure	Time frame
o Quality of life using the VEINES-QoL questionnaire o Symptom severity using the VEINES-Sym questionnaire o PTS score using the Villalta score o VAS score o Leg circumference in centimetres using a measuring tape	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)