Intermittent Pneumatic Compression to Improve Revascularization Outcome

Peripheral Arterial Disease Clinical Trial

Official title:

Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250675
• Other study ID #: 1907961196
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Restenosis following revascularization procedures occur frequently and as early as 3 months after the intervention. There is an urgent need for adjunctive therapies that aid in the improvement of tissue blood flow and consequently relieve pain and improve functional capacity in these patients. It has been previously shown that exposure to IPC enhances leg blood flow to collateral-dependent tissues. In this study, subjects who have undergone nonsurgical revascularization will be randomly assigned to two groups: IPC or placebo pump. Subjects will receive a commercially available IPC device (Art Assist, ACI Medical, San Marcos, CA) and will apply the treatment at home for 2 hours daily over 3 consecutive months. At 3 time points (pre, 1 and 3 months post procedure) assessments will be performed (hemodynamics, rest pain, calf muscle oxygenation during exercise, walking endurance and quality of life).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Scheduled for endovascular revascularization of one or both lower extremities.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Intermittent pneumatic leg compressions
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.
• Sham
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.

Locations

Country	Name	City	State
United States	IU Health Methodist	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Roseguini, Bruno, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking endurance	Change in 6 Minute Walk Test from baseline to 3 months	Baseline and after 1 and 3 months of treatment
Secondary	Ankle-brachial index (ABI)	Change in ABI from baseline to 3 months	Baseline and after 1 and 3 months of treatment
Secondary	Toe-brachial index (TBI)	Change in TBI from baseline to 3 months	Baseline and after 1 and 3 months of treatment
Secondary	Transcutaneous Oxygen Pressure at the dorsum of the foot (TcPO2)	Change in TcPO2 from baseline to 3 months	Baseline and after 1 and 3 months of treatment
Secondary	Rest leg pain	Change in Visual Analog Scale Pain Scale Ruler score (0-100) from baseline to 3 months. 0mm=no pain, 100mm=extreme pain.	Baseline and after 1 and 3 months of treatment
Secondary	Calf circumference	Change in calf circumference tape measure measurement from baseline to 3 months	Baseline and after 1 and 3 months of treatment
Secondary	Vascular Quality of Life Score (VascuQol)	Change in scores for VascuQol Questionnaire from baseline to 3 months. Overall score range is 7-175; higher score means higher quality of life.	Baseline and after 1 and 3 months treatment
Secondary	Quality of Life Score - Short Form-36	Change in scores for Short Form-36 Questionnaire from baseline to 3 months. Eight health concepts scored 0-100 range. High score is a more favorable health state.	Baseline and after 1 and 3 months treatment
Secondary	Blood level marker of coagulation - D-Dimer	Change in D-Dimer levels from baseline to 3 months	Baseline and after 1 and 3 months treatment
Secondary	Blood level marker of coagulation - PT/INR	Change in PT/INR level from baseline to 3 months	Baseline and after 1 and 3 months treatment
Secondary	Blood level marker of coagulation - thrombin time	Change in thrombin levels from baseline to 3 months	Baseline and after 1 and 3 months treatment
Secondary	Blood level marker of fibrinolysis - fibrinogen	Change in fibrinogen levels from baseline to 3 months	Baseline and after 1 and 3 months treatment