Recruiting

TENS & Controlled Heat

Sponsor:

Western Michigan University

Code:

NCT07063524

Conditions

Diabetes

Heat

Perfusion; Complications

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Electrical stimulation

Study Details

Brief summary:

The investigators would like to see if the combination of TENS and controlled heat in a boot increases blood flow to the foot more than baseline or heat alone in people with and without diabetes. This may help people with diabetes and a diabetic wound that will not heal.

Conditions

Diabetes

Heat

Perfusion; Complications

Study ID

NCT07063524

Start date

May 10, 2024

Status verified date

Jul, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male or Female aged between 45-75 years old
  • Clinical diagnosis of Type I or Type II diabetes
  • Controlled diabetes mellitus (HbA1c ≤ 7%)

Exclusion Criteria:

  • Pregnancy
  • Current smoker
  • Diagnosed neuropathy
  • Uncontrolled hypertension (HTN)
  • Allergy to tape or electrodes
  • Diagnosis of dementia
  • History of knee joint replacement
  • Significant joint pain (e.g., back, hip, or ankle) that may limit the ability to wear a boot for 60 minutes
  • Contraindications to TENS, including:

  • Presence of pacemakers
  • Dermatological conditions
  • Abnormal sensation in the knees
  • Severe medical or neurological conditions, including:

  • Chronic obstructive pulmonary disease
  • Cardiovascular disease
  • Arteriosclerosis obliterans
  • Cerebrovascular accident
  • Lumbar disc disorders (e.g., herniation)
  • Rheumatoid arthritis
  • Fear of electrical stimulation

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blood perfusion

Blood flow at the foot with the application of heat and electrical stimulation

Interventions

Electrical stimulation

Electrical stimulation with controlled heat during the intervention

Primary outcome measure

  • Blood Perfusion [ Time Frame: During 30 minutes of electrical stimulation and heat application. ]

Central Contacts and Locations

Central contacts

Massood Atashbar, PhD

2692763148massood.atashbar@wmich.edu

Locations

Western Michigan University

Recruiting

Kalamazoo, Michigan, United States, 49008

Contacts

Daryl Lawson, PT, DSc

(269) 387-7266daryl.lawson@wmich.edu

More Information

Sponsor

Western Michigan University

Last update posted

Jul 14, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western Michigan University on 2025-07-14.