Intervention group for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hamad Medical Corporation, Doha, Qatar
Diabetes Mellitus+3 More
Tennant Biomodulator ® - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A high prevalence of diabetes has been reported in Qatar with nearly 23% population suffering from the pandemic, thereby increasing the associated healthcare cost. Low compliance with exercise and physical activity in patients with diabetes increases foot risk complications, deteriorates health, and further increases economic costs. This is particularly true among patients with diabetes who are undergoing hemodialysis (HD) process. Exercise interventions have been shown to improve mobility and balance, reduce the incidence of falls, and improve peripheral blood flow, which is essential to reduce foot problems and peripheral arterial disease. However, uptake of exercise programs for individuals who are undergoing HD treatment has been limited. The three main factors limiting uptake and adherence among HD patients are time availability, post-dialysis fatigue, and transportation to exercise programs, which are usually offered in rehabilitation departments or cardiovascular centers but not in nephrology departments or in free-standing dialysis clinics. Many of these patients visit clinics 3 times a week to receive hemodialysis, providing an optimal opportunity for intervention. Thus the investigators are proposing an innovative intervention based on plantar electrical stimulation treatment during HD (3 times per week) to enhance balance and quality of life while reducing the risk of peripheral arterial diseases and diabetic foot ulcers, which are highly prevalent among people with diabetes and chronic kidney disease. This interdisciplinary study is based on preliminary studies, in which the investigators demonstrated that regular plantar electrical stimulation is an effective and practical therapy to enhance motor performance and plantar sensation in patients with diabetes. The scientific premise of the proposed intervention has been also supported by literature as well as three systematic reviews suggesting the effectiveness of electrical stimulation to reduce pain, improve balance, improve skin perfusion, and improve plantar sensation. In the context of this study, the investigators propose to bring an innovative technology based on an FDA-cleared bio-electric stimulation technology (BEST®) microcurrent platform, named Tennant Biomodulator® (Avazzia Inc., Dallas, TX, USA), which is a transcutaneous electrical nerve stimulator (TENS) and has been designed for symptomatic relief and management of chronic pain. However, the system was modified to provide electrical stimulation to the plantar area via two electrodes placed on the hind and forefoot area instead of the leg. The device has a 60-minute run cycle after which it automatically turns off. In the context of a previous study funded by QNRF, the investigators developed and tested 50 electrical stimulation units (which will be used in the context of the study), including 25 active systems and 25 placebo systems. The placebo systems are similar to active systems in the appearance and functioning of lights and indicators. However, they were programmed not to provide any electrical current. In a preliminary study, the proof of concept of this revised technology was tested in the context of enhancing balance and skin perfusion in ambulatory patients with diabetes and peripheral neuropathy. In the context of this study, the investigators plan to translate this technology for routine treatment during HD sessions for patients with diabetes who are undergoing regular HD treatment. Using a double-blinded randomized-controlled model, the investigators will validate the effectiveness of this technology to enhance balance, reduce pain, and improve skin perfusion. One hundred (n=100) HD volunteers with diabetes will be recruited and randomized to either intervention (n=50) or control (CG: n=50) group for the purpose of this study. Plantar electrical stimulation will be provided during HD sessions, 3 times per week and for 12 weeks. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks to examine the effectiveness of the proposed intervention to enhance balance, improve quality of life, and improve lower extremity skin perfusion among HD patients with diabetes. This proposal is in line with Qatar National Priorities Research goals and if successful the result will open new doors to managing diabetes and kidney failure. In a setting where no therapeutic agents or interventions effectively address poor balance and loss of protective sensation among HD patients with diabetes and where affected individuals life with a heightened risk of developing a debilitating foot ulcer and quite possibly a disabling amputation, the potential impact from the plantar electrical stimulation system may offer the potential for significant clinical benefit, with very low risk, and with ease of implementation in routine care application for patients who are undergoing HD treatment.

Eligible Conditions

  • Diabetes Mellitus
  • Cardiovascular Complications
  • Quality of Life (QOL)
  • Hemodialysis Complication

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Baseline and12 weeks

Baseline and 12 weeks
Change in cognitive function
Change in fear of falling
Change in gait parameters from baseline to 12 weeks.
Change in quality of life from baseline to 12 weeks.
Change in skin perfusion from baseline to 12 weeks.
Baseline and12 weeks
Change in balance from baseline to 12 weeks
Change in gait speed from baseline to 12 weeks
Baseline to 12 weeks
Change in depression
Change in pain

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Intervention group
1 of 2
Control group
1 of 2
Active Control
Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention group · Has Placebo Group · N/A

Control group
Device
ShamComparator Group · 1 Intervention: Tennant Biomodulator ® · Intervention Types: Device
Intervention group
Device
ActiveComparator Group · 1 Intervention: Tennant Biomodulator ® · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and12 weeks

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are >40 years old.
You are able to walk independently.
Diabetes will be defined based on the American Diabetes Association (ADA) criteria (83).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References