Transcutaneous Electrical Stimulation and Controlled Heat in People With and Without Diabetes
Launched by WESTERN MICHIGAN UNIVERSITY · Jul 2, 2025
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using a special boot that combines gentle electrical stimulation (called TENS) with controlled heat can improve blood flow to the feet. The goal is to see if this combination works better than just heat alone or no treatment. This could be helpful for people with diabetes, especially those who have wounds on their feet that are slow to heal.
People who might be eligible to join are men or women between 45 and 75 years old who have well-controlled type 1 or type 2 diabetes (meaning their blood sugar levels are managed). Participants should not have certain health issues like nerve damage, high blood pressure that isn’t controlled, or other serious medical problems. During the study, participants will wear the special boot for about an hour while the treatment is applied. The research team will then measure how much blood flow improves. This study is currently looking for volunteers and may offer useful information to help improve foot care for people with diabetes.
Gender
ALL
Eligibility 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
About Western Michigan University
Western Michigan University (WMU) is a leading research institution dedicated to advancing health sciences through innovative clinical trials and studies. With a focus on enhancing patient care and outcomes, WMU leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous research in collaboration with various healthcare partners. The university is committed to ethical standards and the highest quality of research practices, aiming to contribute valuable insights to the medical community and improve public health. Through its clinical trials, WMU seeks to address critical health challenges and foster the development of new therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kalamazoo, Michigan, United States
Patients applied
Trial Officials
Massood Atashbar, PhD
Principal Investigator
Western Michigan University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported