Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

NCT01007604 | Unknown Phase 2

• 1 other identifier: 21975
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse pneumatic device (PCD) in the treatment of intermittent claudication in patients having documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA approved for the treatment of venous disease. While anecdotal evidence exists supporting a decrease in claudication symptoms, there are no previously published data on studies employing this compression device in the treatment of arterial disease. The investigators' primary hypothesis is that patients randomized to the intervention arm of the trial will experience an increase in mean walking ability as compared to the group receiving medical standard of care.

Conditions

Intermittent Claudication

Keywords

claudication; pneumatic compression device

Outcome Measures

Primary Outcomes (1)

• Peak walking time (in seconds) during a graded-protocol treadmill test

  initial; 3 months; 6 months

Secondary Outcomes (4)

• Claudication onset time (in seconds) during a graded-protocol treadmill test

  initial; 3 months; six months

• Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale

  initial; 3 months; 6 months

• Ankle-Brachial Index (ABI)

  initial; 3 months; 6 months

• Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth

  initial; 3 months; 6 months

Study Arms (2)

Exercise and lifestyle counselling

ACTIVE COMPARATOR

Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.

Other: Exercise and lifestyle counseling

PCD with peristaltic pulse waveform

EXPERIMENTAL

Daily use for two hours

Device: Peristaltic pulse PCD

Interventions

Peristaltic pulse PCD DEVICE

Daily use for two hours

Also known as: NormaTec PCD, Exercise and lifestyle counselling

PCD with peristaltic pulse waveform

Exercise and lifestyle counseling OTHER

Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.

Also known as: Ambulatory exercise, Smoking cessation counseling

Exercise and lifestyle counselling

Eligibility Criteria

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

You may qualify if:

• Consistent claudication symptoms for at least 6 months
• ABIs at rest as follows: 0.5\>ABI\<0.8 minimally on one leg

You may not qualify if:

• Refuses to consent
• Unlikely to be compliant with protocol
• Unable to perform treadmill test
• Current use of Cilostazol (Pletal) or Pentoxyphylline (Trental)
• Lower extremity surgery or endovascular procedure within the last 3 months
• Currently has a non-healing wound on either leg
• DVT in the past 3 months
• Unstable hypertension, angina, uncontrolled glucose levels
• Participating in a supervised exercise regimen
• Claudication medications regime changed within the last 3 months
• Diagnosis of Raynaud's Disease
• Requires a custom fabricated boot appliance

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead
• NormaTec Industries LP: collaborator

Study Sites (1)

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Exercise Therapy; Exercise

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sharon R Besso, MS, ARNP

  White River Junction Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

• Joseph P Duggan, DPM

  White River Junction Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon R Besso, MS, ARNP

CONTACT

802-295-9363; sharon.besso@va.gov

Joseph P Duggan, DPM

CONTACT

802-295-9363; joseph.duggan@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 4, 2009

Record last verified: 2009-11

Locations

US (1)