RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Principle Investigator

Quick Facts

Study Start:2024-05-10
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07063524

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female aged between 45-75 years old
  2. * Clinical diagnosis of Type I or Type II diabetes
  3. * Controlled diabetes mellitus (HbA1c ≤ 7%)
  1. * Pregnancy
  2. * Current smoker
  3. * Diagnosed neuropathy
  4. * Uncontrolled hypertension (HTN)
  5. * Allergy to tape or electrodes
  6. * Diagnosis of dementia
  7. * History of knee joint replacement
  8. * Significant joint pain (e.g., back, hip, or ankle) that may limit the ability to wear a boot for 60 minutes
  9. * Contraindications to TENS, including:
  10. * Presence of pacemakers
  11. * Dermatological conditions
  12. * Abnormal sensation in the knees
  13. * Severe medical or neurological conditions, including:
  14. * Chronic obstructive pulmonary disease
  15. * Cardiovascular disease
  16. * Arteriosclerosis obliterans
  17. * Cerebrovascular accident
  18. * Lumbar disc disorders (e.g., herniation)
  19. * Rheumatoid arthritis
  20. * Fear of electrical stimulation

Contacts and Locations

Study Contact

Massood Atashbar, PhD
CONTACT
2692763148
massood.atashbar@wmich.edu

Principal Investigator

Massood Atashbar, PhD
PRINCIPAL_INVESTIGATOR
Western Michigan University

Study Locations (Sites)

Western Michigan University
Kalamazoo, Michigan, 49008
United States

Collaborators and Investigators

Sponsor: Western Michigan University

  • Massood Atashbar, PhD, PRINCIPAL_INVESTIGATOR, Western Michigan University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-10
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-05-10
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes
  • Heat
  • Perfusion; Complications