Transcutaneous Electrical Stimulation and Controlled Heat in People With and Without Diabetes

NCT07063524 | Recruiting FDA Device

• 1 other identifier: 201131
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Blood Perfusion

  Peripheral Blood Perfusion and Oxygen Saturation (SpO₂) assessed using pulse oximetry.

  During 30 minutes of electrical stimulation and heat application.

Study Arms (1)

Blood perfusion

EXPERIMENTAL

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

Device: Electrical stimulation

Interventions

Electrical stimulation DEVICE

Electrical stimulation with controlled heat during the intervention

Also known as: controlled heat

Blood perfusion

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Michigan University: lead

Study Sites (1)

Western Michigan University

Kalamazoo, Michigan, 49008, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Massood Atashbar, PhD

  Western Michigan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massood Atashbar, PhD

CONTACT

2692763148; massood.atashbar@wmich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Pilot study of a single group of people with and without diabetes.

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: July 14, 2025
• Study Start: May 10, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)