Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorWestern Michigan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or Female aged between 45-75 years old
Clinical diagnosis of Type I or Type II diabetes
Controlled diabetes mellitus (HbA1c ≤ 7%)
Disqualifiers
Pregnancy
Current smoker
Diagnosed neuropathy
Uncontrolled hypertension (HTN)
Trial design
Design model
Single group
Treatments tested in this trial
Electrical stimulation
DeviceElectrical stimulation with controlled heat during the intervention
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Blood perfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood Perfusion
Peripheral Blood Perfusion and Oxygen Saturation (SpO₂) assessed using pulse oximetry.
Time frame
During 30 minutes of electrical stimulation and heat application.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov