Active Comparator - Intermittent Pneumatic Compression for Peripheral Arterial Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Peripheral Arterial DiseaseIntermittent pneumatic leg compressions - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial looks at whether using a machine to pump up and squeeze the legs can improve circulation and walking distance following a nonsurgical vascular procedure.

Eligible Conditions
  • Peripheral Arterial Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline and after 1 and 3 months treatment

Month 3
Ankle-brachial index (ABI)
Calf circumference
Rest leg pain
Toe-brachial index (TBI)
Transcutaneous Oxygen Pressure at the dorsum of the foot (TcPO2)
Walking endurance
Month 3
Blood level marker of coagulation - D-Dimer
Blood level marker of coagulation - PT/INR
Blood level marker of coagulation - thrombin time
Blood level marker of fibrinolysis - fibrinogen
Quality of Life Score - Short Form-36
Vascular Quality of Life Score (VascuQol)

Trial Safety

Safety Progress

1 of 3

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L-Arginine
1
Dietary nitrate
3
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Trial Design

2 Treatment Groups

Active Comparator - Intermittent Pneumatic Compression
1 of 2
Sham
1 of 2

Active Control

Non-Treatment Group

8 Total Participants · 2 Treatment Groups

Primary Treatment: Active Comparator - Intermittent Pneumatic Compression · Has Placebo Group · N/A

Active Comparator - Intermittent Pneumatic Compression
Device
ActiveComparator Group · 1 Intervention: Intermittent pneumatic leg compressions · Intervention Types: Device
Sham
Device
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and after 1 and 3 months treatment

Who is running the clinical trial?

Roseguini, Bruno, PhDINDIV
3 Previous Clinical Trials
57 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
57 Patients Enrolled for Peripheral Arterial Disease
Bruno Roseguini, PhDUNKNOWN
3 Previous Clinical Trials
57 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
57 Patients Enrolled for Peripheral Arterial Disease
Indiana UniversityLead Sponsor
876 Previous Clinical Trials
749,547 Total Patients Enrolled
6 Trials studying Peripheral Arterial Disease
211 Patients Enrolled for Peripheral Arterial Disease

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You are scheduled for endovascular revascularization of one or both lower extremities.
References

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