What is this study trying to find out about blood flow in people with and without diabetes?

This study is evaluating whether combining electrical stimulation with controlled heat in a boot can increase blood flow to the foot more than heat alone or baseline. It aims to help understand better treatments for diabetic wounds that do not heal well. The research is sponsored by Western Michigan University and involves careful monitoring of blood flow and other health measures.

Who may be eligible for this diabetes clinical trial?

Adults aged 45 to 75 years with a clinical diagnosis of Type I or Type II diabetes and controlled blood sugar levels (HbA1c ≤ 7%) may be eligible. Both males and females can participate. People who smoke, have neuropathy, or certain medical conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetes clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses to attend the study are not guaranteed to be covered and may vary. Participants can expect that the study will cover all procedures related to the research itself.

Actively Recruiting

Phase Not Applicable

Age: 45Years - 75Years

All Genders

Healthy Volunteers

ID07063524

Study of Electrical Stimulation and Controlled Heat to Improve Foot Blood Flow in Adults With and Without Diabetes

Led by Western Michigan University · Updated on 2025-07-14

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether combining transcutaneous electrical nerve stimulation TENS with controlled heat in a specially designed boot can increase blood flow to the foot more than heat alone or baseline conditions. This study includes people with and without diabetes and aims to provide insights that could help those with diabetic wounds that are difficult to heal. Participants will sit comfortably while measurements of temperature, oxygen saturation, and heart rate are taken. A boot equipped with sensors will then be placed on the dominant leg. After baseline measurements, blood flow will be monitored during periods of heat alone and then during combined heat and electrical stimulation. The heat will be controlled between 36-38 degrees Celsius, and the electrical stimulation intensity will be adjusted for comfort without causing muscle contractions. Throughout the study, blood perfusion in the foot will be continuously recorded using sensors embedded in the boots insole. The total intervention with heat and electrical stimulation lasts 30 minutes, followed by a 10-minute final measurement period without stimulation. Participants will undergo multiple assessments, including pulse oximetry and temperature readings, to monitor safety and responses during the procedure. The study lasts for a single session with detailed data collection.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years - 75Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Male or Female aged between 45-75 years old
Clinical diagnosis of Type I or Type II diabetes
Controlled diabetes mellitus (HbA1c 6 7%)

You will not qualify if you...

Pregnancy
Current smoker
Diagnosed neuropathy
Uncontrolled hypertension
Allergy to tape or electrodes
Diagnosis of dementia
History of knee joint replacement
Significant joint pain limiting ability to wear a boot for 60 minutes
Contraindications to TENS such as pacemakers, dermatological conditions, or abnormal knee sensation
Severe medical or neurological conditions including COPD, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumbar disc disorders, rheumatoid arthritis
Fear of electrical stimulation

Research Team

Massood Atashbar, PhD

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