NCT03462472

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

February 13, 2018

Last Update Submit

March 5, 2018

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Distance walked during six-minute walk test

    Distance walked during a self-paced six-minute walk

    35 minutes post-intervention/control

Secondary Outcomes (4)

  • Popliteal artery blood flow

    Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control

  • Time/distance to claudication during six-minute walk

    35 minutes following each intervention and control period

  • Ankle brachial index (ABI)

    Pre-intervention baseline and 20 minutes post-intervention/control

  • Toe oxygen saturation

    Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control

Study Arms (5)

15 minute lower leg heating

EXPERIMENTAL
Behavioral: Lower leg heating

45 minute lower leg heating

EXPERIMENTAL
Behavioral: Lower leg heating

Control

NO INTERVENTION

15 minute lower leg TENS

EXPERIMENTAL
Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS)

45 minute lower leg TENS

EXPERIMENTAL
Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS)

Interventions

Lower leg heatingBEHAVIORAL

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

15 minute lower leg heating45 minute lower leg heating
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

15 minute lower leg TENS45 minute lower leg TENS

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salisbury University

Salisbury, Maryland, 21801, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Thomas K. Pellinger, Ph.D.

    Salisbury University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Pellinger, Ph.D.

CONTACT

410-677-0144tkpellinger@salisbury.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

March 12, 2018

Study Start

November 15, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 12, 2018

Record last verified: 2018-03

Locations

US(1)