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

Recruiting now · Not applicable

Conditions studied: Diabetes, Heat, Perfusion; Complications

In brief

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.

Key facts

Study ID

NCT07063524

Run by

Western Michigan University

People needed

20

Starts

2024-05-10

Expected to finish

2025-12-30

Last updated by the study team

2025-07-14

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Western Michigan University — Kalamazoo, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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