Peripheral Arterial Disease
Conditions
Brief summary
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).
Interventions
BEHAVIORALLower leg heating
Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius
BEHAVIORALLower leg transcutaneous electrical nerve stimulation (TENS)
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
Sponsors
Salisbury University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Intermittent claudication (Fontaine Stage II) * Resting ankle-brachial index (ABI) \< 0.90 * Ability to walk \> 60 meters in six minutes
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance walked during six-minute walk test | 35 minutes post-intervention/control | Distance walked during a self-paced six-minute walk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Popliteal artery blood flow | Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control | Unilateral popliteal blood flow measured via Doppler ultrasound |
| Time/distance to claudication during six-minute walk | 35 minutes following each intervention and control period | Subjects give subjective ratings of claudication onset, if applicable, during six-minute walk test |
| Ankle brachial index (ABI) | Pre-intervention baseline and 20 minutes post-intervention/control | 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 |
| Toe oxygen saturation | Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control | A pulse oximeter is used to measure toe oxygen saturation in the big toe of each of the subject's feet |
Countries
United States
Contacts
Primary ContactTom Pellinger, Ph.D.
Outcome results
None listed