TENS plus controlled heat to increase blood flow in the foot
Official title: Principle Investigator
Run by Western Michigan University · NCT07063524 · Data updated 2026-11-12
Try using gentle electrical stimulation (TENS) together with controlled heat in a boot to see if it increases blood flow to the foot in adults with diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Western Michigan University Academic / other |
| Locations | 1 site (Kalamazoo, Michigan) |
| Status | Recruiting |
| Started | May 10, 2024 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | July 14, 2025 |
| Trial ID | NCT07063524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 45–75 with well-controlled Type 1 or Type 2 diabetes (HbA1c ≤ 7%), without neuropathy or major cardiovascular/pulmonary disease, who can tolerate wearing a boot for about 60 minutes.
✕Probably not a fit
People with uncontrolled diabetes, diagnosed neuropathy, pacemakers, severe cardiovascular or pulmonary disease, active skin conditions, current smokers, pregnant people, or those unable to wear the boot are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This protocol measures short-term changes in foot blood flow when participants wear a heated boot with and without transcutaneous electrical nerve stimulation (TENS). Participants rest while baseline temperature, SpO2, and heart rate are recorded, then a pulse oximeter and a PPG sensor embedded in an insole record perfusion during each condition. Blood flow is recorded for short (five-minute) periods to compare baseline, heat alone, and heat plus TENS within the same individual. The procedure is noninvasive and performed as a single outpatient visit.
Why it matters
Potential benefit: If successful, the combination could improve foot circulation and help heal or prevent diabetic foot wounds.
How similar studies have gone: Prior small studies show that local heating and TENS can separately increase peripheral blood flow, but combining TENS with a controlled heated boot is a relatively novel approach with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Western Michigan University
Kalamazoo, Michigan, United States Recruiting
Study contacts
- Principal investigator: Massood Atashbar, PhD — Western Michigan University
- Study coordinator: Massood Atashbar, PhD
- Email: massood.atashbar@wmich.edu
- Phone: 2692763148
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.