Recruiting

Lower Leg Heating & TENS

Sponsor:

Salisbury University

Code:

NCT03462472

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Lower leg heating

Lower leg transcutaneous electrical nerve stimulation (TENS)

Study Details

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).

Conditions

Peripheral Arterial Disease

Study ID

NCT03462472

Start date

Nov 15, 2015

Status verified date

Mar, 2018

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 15 minute lower leg heating

experimental: 45 minute lower leg heating

no intervention: Control

experimental: 15 minute lower leg TENS

experimental: 45 minute lower leg TENS

Interventions

Lower leg heating

Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius

Lower 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

Primary outcome measure

  • Distance walked during six-minute walk test [ Time Frame: 35 minutes post-intervention/control ]

Central Contacts and Locations

Central contacts

Tom Pellinger, Ph.D.

410-677-0144tkpellinger@salisbury.edu

Locations

Salisbury University

Recruiting

Salisbury, Maryland, United States, 21801

Contacts

Tom Pellinger, Ph.D.

410-677-0144tkpellinger@salisbury.edu

More Information

Sponsor

Salisbury University

Last update posted

Mar 12, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salisbury University on 2018-03-12.