Randomized controlled trial of vacuum therapy for intermittent claudication

Area of Science:

• Vascular Medicine
• Rehabilitation Therapy
• Clinical Trials

Background:

• Supervised exercise therapy (SET) is the established treatment for intermittent claudication (IC).
• Intermittent vacuum therapy (IVT) is a novel treatment proposed to enhance circulation in IC patients.
• The study investigates if IVT provides additional benefits when used alongside SET.

Purpose of the Study:

• To evaluate the additive effect of Intermittent Vacuum Therapy (IVT) in patients with Intermittent Claudication (IC) undergoing standard Supervised Exercise Therapy (SET).
• To assess changes in maximal and functional treadmill walking distances, 6-minute walk test, ambulatory ability, and quality of life.

Main Methods:

• A randomized controlled trial involving 78 IC patients receiving standardized SET.
• Patients were assigned to either IVT (n=36) or a sham treatment (control, n=34) for 12 sessions over 6 weeks.
• Primary outcome was the change in maximal treadmill walking distance at 12 weeks.

Main Results:

• No significant difference in the change of maximal treadmill walking distance between the IVT and control groups at 12 weeks (+250m vs +335m, P=.109).
• Functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life showed similar improvements in both groups.
• The addition of IVT to SET did not lead to superior outcomes compared to SET alone.

Conclusions:

• Intermittent vacuum therapy (IVT) does not provide additional therapeutic benefits for intermittent claudication (IC) patients already participating in a supervised exercise therapy (SET) program.
• Current evidence suggests IVT is not a beneficial adjunct to standard SET for improving walking capacity or quality of life in IC.