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RecruitingNot ApplicableNCT07063524

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

Principle Investigator

Sponsor

Western Michigan University

Enrollment

20 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

DiabetesHeatPerfusion; Complications

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.

Eligibility

Min Age: 45 YearsMax Age: 75 Years

Inclusion Criteria3

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

Exclusion Criteria20

  • 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

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Interventions

DEVICEElectrical stimulation

Electrical stimulation with controlled heat during the intervention

Locations(1)

Western Michigan University

Kalamazoo, Michigan, United States

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NCT07063524

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