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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 minute lower leg heating | Experimental |
| |
| 45 minute lower leg heating | Experimental |
| |
| Control | No Intervention | ||
| 15 minute lower leg TENS | Experimental |
| |
| 45 minute lower leg TENS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower leg heating | Behavioral | Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance walked during six-minute walk test | Distance walked during a self-paced six-minute walk | 35 minutes post-intervention/control |
| Measure | Description | Time Frame |
|---|---|---|
| Popliteal artery blood flow | Unilateral popliteal blood flow measured via Doppler ultrasound | Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control |
| Time/distance to claudication during six-minute walk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom Pellinger, Ph.D. | Contact | 410-677-0144 | tkpellinger@salisbury.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas K. Pellinger, Ph.D. | Salisbury University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salisbury University | Recruiting | Salisbury | Maryland | 21801 | United States |
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| Lower leg transcutaneous electrical nerve stimulation (TENS) | Behavioral | Bilateral lower leg transcutaneous electrical nerve stimulation (TENS) using burst mode at a 3Hz burst rate, 100Hz frequency, and 250 µs pulse duration, sufficient to evoke skeletal muscle contraction |
|
Subjects give subjective ratings of claudication onset, if applicable, during six-minute walk test
| 35 minutes following each intervention and control period |
| Ankle brachial index (ABI) | Systolic blood pressures (SBP) are measured in the brachial arteries of both arms and in the posterior tibial and dorsalis pedis arteries of both ankles using a hand-held Doppler ultrasound probe and a sphygmomanometer | Pre-intervention baseline and 20 minutes post-intervention/control |
| Toe oxygen saturation | A pulse oximeter is used to measure toe oxygen saturation in the big toe of each of the subject's feet | Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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