Effect of Lower Leg Heating and Transcutaneous Electrical Nerve Stimulation on Exercise Capacity in Patients With PAD

Status unconfirmed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. The aim of this research protocol is to determine the effect of two non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD. Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation (TENS).

Key facts

Study ID

NCT03462472

Run by

Salisbury University

People needed

10

Starts

2015-11-15

Expected to finish

2018-06-01

Last updated by the study team

2018-03-12

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Intermittent claudication (Fontaine Stage II)
• Resting ankle-brachial index (ABI) < 0.90
• Ability to walk > 60 meters in six minutes

You may not qualify if…

• Body mass index (BMI) > 35 kg/m2
• Severe exercise limitations (more than PAD) due to co-morbidity
• Taking illegal/recreational drugs
• Uncontrolled hypertension (>180/100 mmHg)
• Severe peripheral neuropathy
• Foot ulcers
• Gangrene
• Pregnant or breast feeding

Where it is running

• Salisbury University — Salisbury, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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