Intermittent Pneumatic Compression to Improve Revascularization Outcome

NCT04250675 | Completed Results DMC FDA Device

• 1 other identifier: 1907961196
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether daily treatment with intermittent pneumatic leg compressions (IPC) following a nonsurgical vascular procedure improves circulation and enhances walking distance.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Walking Endurance

  Change in 6 Minute Walk Test from baseline to 3 months

  Baseline and after 1 and 3 months of treatment

Secondary Outcomes (3)

• Ankle-brachial Index (ABI)

  Baseline and after 3 months of treatment

• Vascular Quality of Life Score (VascuQol)

  Baseline and after 1 and 3 months treatment

• Toe-brachial Index

  Baseline and after 1 and 3 months of treatment

Study Arms (2)

Sham

SHAM COMPARATOR

Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs.

Device: Sham

Active Comparator - Intermittent Pneumatic Compression

ACTIVE COMPARATOR

Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs.

Device: Intermittent pneumatic leg compressions

Interventions

Intermittent pneumatic leg compressions DEVICE

Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.

Active Comparator - Intermittent Pneumatic Compression

Sham DEVICE

Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Scheduled for endovascular revascularization of one or both lower extremities.

You may not qualify if:

• Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula)
• Open and/or non-healing wounds in the areas covered by IPC cuff
• Walking limited by a symptom other than PAD
• Presence of any clinical condition that makes the patient unsuitable to participate in the trial
• Concern for inability of the patient to comply with study procedures and/or follow-up

Sponsors & Collaborators

• Indiana University: lead
• Roseguini, Bruno, PhD: collaborator

Study Sites (1)

IU Health Methodist

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Bruno Roseguini
• Organization: Purdue University

brosegui@purdue.edu

7654906284

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: January 31, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-08

Locations

US (1)