DiabetesTENSNCT07063524
Transcutaneous Electrical Stimulation and Controlled Heat in People With and Without Diabetes
A study testing Electrical stimulation in people with Diabetes and Heat, run by Western Michigan University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Heat, Perfusion; Complications
- What is being tested?
- Electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female aged between 45-75 years old
- Clinical diagnosis of Type I or Type II diabetes
- Controlled diabetes mellitus (HbA1c ≤ 7%)
Who cannot join
- Pregnancy
- Current smoker
- Diagnosed neuropathy
- Uncontrolled hypertension (HTN)
- Allergy to tape or electrodes
- Diagnosis of dementia
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Western Michigan University
Kalamazoo, Michigan, 49008
Daryl Lawson, PT, DSc, (269) 387-7266, daryl.lawson@wmich.edu
About this study
Official title: Principle Investigator
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.
Read the detailed description
Procedure
- Sit comfortably in a reclining chair for 5 minutes while temperature, SPO2, and heart rate are taken, and any further questions can be answered with a pulse oximeter and temperature
- The procedure for temperature, heart rate, and blood saturation rate will be taken using a Homedics Non-Contact Infrared Thermometer. The infrared beam will be pointed at the subject's forehead at approximately 1 foot away, and within 2 seconds, the temperature will be recorded and time-stamped.
- Procedure for the Pulse Oximeter- A SPO2 Pulse Oximeter will be placed on the subject's foot. The SPO2 sensors are embedded in the insole. The oxygen saturation level and pulse rate will be documented. The pulse oximeter will be cleaned with isopropyl alcohol before and after each use.
- Temperature
- The procedure for taking Room temperature-Reading of the room temperature via the thermostat located in the lab.
- Once the baseline temperature, SPO2, heart rate, and room temperature are documented, a PPG sensor will be located and embedded in the insole.
- Procedure for a PPG sensor- A PPG sensor is very similar to the pulse oximeter on the finger. The PPG also works on infrared light, similar to the pulse oximeter, and will data collection throughout the experiment.
- 5-min of blood perfusion will be recorded at the dominant leg/foot.
- Procedure for recording blood perfusion- Once the subject's foot is on the insole, recordings of blood perfusion can be made from software. The PPG sensor will have a lead wire that connects to a USB port from the PPG to the computer for the data.
- A boot will be placed on the patient's dominant leg with the subject still sitting; once comfortable with the boot, 5-more minutes of blood perfusion will be measured
- Procedure for putting on the boot- This boot is commercially available. The subject will put their foot into a padded insole, and straps will secure the foot and portion that goes up to the knee (picture below). The straps can be fastened to the subject comfort. It should not feel too tight or uncomfortable.
- After 5 minutes of just the boot, the controlled heat in the boot will be turned on, and blood perfusion will be measured for 5 minutes. The heat will never be higher than 36-38 degrees C.
- Procedure for using controlled heat in the boot-With in the boot, five thermistors emit heat and are designed to increase heat. Once the heat is turned on, warmth will be felt at the subject foot and leg. The subjects and PI can see a digital readout of the heat on the computer screen. The temperature will not go higher than 38 deg C and be kept in the 36-38 deg C range. Past research has shown that this is a comfortable and safe approach.6-9 But the subjects are in full control of the heat, and the investigators can turn it down if it feels too warm.
- After 5 minutes of heat, electrical stimulation will be added. It will be turned to an intensity that is comfortable to the subject but not high enough for a muscle contraction. The intensity will never be higher than 20 milliamps.
- Procedure for Electrical stimulation- An electrical stimulator with non-adhesive electrodes embedded in the insole will be used. 4-electrodes will be activated at the insole at the bottom of the foot. The electrodes are connected to an electrical stimulator. The intensity of the stimulus will never be high enough to cause a muscle contraction and be uncomfortable for the subject. The subject will be asked if they are comfortable and given the option to decrease or increase the stimulus (throughout the data collection). The intensity will never be over 20 mA.
- This combination of electrical stimulation and heat will last 30 minutes while blood perfusion is measured.
- The procedure of controlled heat and electrical stimulation software will measure both the input of the heat and electrical stimulation, with the safety of the controlled heat, which will never go above 38 degrees C. The subject will always control the electrical stimulation and never experience any discomfort. The subject should not feel any muscle contraction or go over 20 milliamps with the intensity.
- After 30 minutes, all elements will be turned off, and a final measurement will be made for 10-min.
- Recording blood perfusion with electrical stimulation and heat. The electrical stimulation and heat units will be turned off, but the PPG sensors located in the insole will collect blood perfusion readings while the subjects are sitting in a chair.
- Conditions
- Diabetes, Heat, Perfusion; Complications
- Being tested
- Electrical stimulation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationDevice
Also called controlled heat
Electrical stimulation with controlled heat during the intervention
| Study group | Role | What they receive |
|---|---|---|
| Blood perfusion | Experimental | Blood flow at the foot with the application of heat and electrical stimulation Receives: Device: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Perfusion
Peripheral Blood Perfusion and Oxygen Saturation (SpO₂) assessed using pulse oximetry.
Measured: During 30 minutes of electrical stimulation and heat application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start10 May 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study of a single group of people with and without diabetes.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Michigan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massood Atashbar, Western Michigan University
- Investigators
- Massood Atashbar, PhD, Principal investigator, Western Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063524
- Sponsor's protocol ID
- 201131
- Acronym
- TENS
- Status last verified
- Jul 2025
- First submitted
- 10 May 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principle Investigator
- ClinicalTrials.gov ID
- NCT07063524
- Acronym / sponsor ID
- TENS / 201131
- Conditions
- Diabetes, Heat, Perfusion; Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western Michigan UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Procedure
- Sit comfortably in a reclining chair for 5 minutes while temperature, SPO2, and heart rate are taken, and any further questions can be answered with a pulse oximeter and temperature
- The procedure for temperature, heart rate, and blood saturation rate will be taken using a Homedics Non-Contact Infrared Thermometer. The infrared beam will be pointed at the subject's forehead at approximately 1 foot away, and within 2 seconds, the temperature will be recorded and time-stamped.
- Procedure for the Pulse Oximeter- A SPO2 Pulse Oximeter will be placed on the subject's foot. The SPO2 sensors are embedded in the insole. The oxygen saturation level and pulse rate will be documented. The pulse oximeter will be cleaned with isopropyl alcohol before and after each use.
- Temperature
- The procedure for taking Room temperature-Reading of the room temperature via the thermostat located in the lab.
- Once the baseline temperature, SPO2, heart rate, and room temperature are documented, a PPG sensor will be located and embedded in the insole.
- Procedure for a PPG sensor- A PPG sensor is very similar to the pulse oximeter on the finger. The PPG also works on infrared light, similar to the pulse oximeter, and will data collection throughout the experiment.
- 5-min of blood perfusion will be recorded at the dominant leg/foot.
- Procedure for recording blood perfusion- Once the subject's foot is on the insole, recordings of blood perfusion can be made from software. The PPG sensor will have a lead wire that connects to a USB port from the PPG to the computer for the data.
- A boot will be placed on the patient's dominant leg with the subject still sitting; once comfortable with the boot, 5-more minutes of blood perfusion will be measured
- Procedure for putting on the boot- This boot is commercially available. The subject will put their foot into a padded insole, and straps will secure the foot and portion that goes up to the knee (picture below). The straps can be fastened to the subject comfort. It should not feel too tight or uncomfortable.
- After 5 minutes of just the boot, the controlled heat in the boot will be turned on, and blood perfusion will be measured for 5 minutes. The heat will never be higher than 36-38 degrees C.
- Procedure for using controlled heat in the boot-With in the boot, five thermistors emit heat and are designed to increase heat. Once the heat is turned on, warmth will be felt at the subject foot and leg. The subjects and PI can see a digital readout of the heat on the computer screen. The temperature will not go higher than 38 deg C and be kept in the 36-38 deg C range. Past research has shown that this is a comfortable and safe approach.6-9 But the subjects are in full control of the heat, and the investigators can turn it down if it feels too warm.
- After 5 minutes of heat, electrical stimulation will be added. It will be turned to an intensity that is comfortable to the subject but not high enough for a muscle contraction. The intensity will never be higher than 20 milliamps.
- Procedure for Electrical stimulation- An electrical stimulator with non-adhesive electrodes embedded in the insole will be used. 4-electrodes will be activated at the insole at the bottom of the foot. The electrodes are connected to an electrical stimulator. The intensity of the stimulus will never be high enough to cause a muscle contraction and be uncomfortable for the subject. The subject will be asked if they are comfortable and given the option to decrease or increase the stimulus (throughout the data collection). The intensity will never be over 20 mA.
- This combination of electrical stimulation and heat will last 30 minutes while blood perfusion is measured.
- The procedure of controlled heat and electrical stimulation software will measure both the input of the heat and electrical stimulation, with the safety of the controlled heat, which will never go above 38 degrees C. The subject will always control the electrical stimulation and never experience any discomfort. The subject should not feel any muscle contraction or go over 20 milliamps with the intensity.
- After 30 minutes, all elements will be turned off, and a final measurement will be made for 10-min.
- Recording blood perfusion with electrical stimulation and heat. The electrical stimulation and heat units will be turned off, but the PPG sensors located in the insole will collect blood perfusion readings while the subjects are sitting in a chair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study of a single group of people with and without diabetes.
| Arm | Type | Receives |
|---|---|---|
| Blood perfusion | Experimental | Device: Electrical stimulationBlood flow at the foot with the application of heat and electrical stimulation |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female aged between 45-75 years old
- Clinical diagnosis of Type I or Type II diabetes
- Controlled diabetes mellitus (HbA1c ≤ 7%)
Key exclusion criteria (20 listed)
- Pregnancy
- Current smoker
- Diagnosed neuropathy
- Uncontrolled hypertension (HTN)
- Allergy to tape or electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulationAlso: controlled heatElectrical stimulation with controlled heat during the intervention | Device | Blood perfusion |
Primary outcome
Blood Perfusion
Time frame: During 30 minutes of electrical stimulation and heat application.
Peripheral Blood Perfusion and Oxygen Saturation (SpO₂) assessed using pulse oximetry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massood Atashbar, PhD principal investigator
Western Michigan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation in people with Diabetes and Heat, run by Western Michigan University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massood Atashbar, PhD (2692763148, massood.atashbar@wmich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Perfusion (time frame: During 30 minutes of electrical stimulation and heat application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.