Electrical Stimulation for Diabetes

(TENS Trial)

Overseen By Massood Atashbar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western Michigan University

Disqualifiers: Pregnancy, Smoker, Neuropathy, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 30 minutes

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a boot combining electrical stimulation and heat can improve blood flow to the feet. It focuses on helping people with diabetes who have non-healing foot wounds. Participants should have controlled diabetes and no conditions such as smoking, neuropathy (nerve damage), or significant joint pain that would hinder wearing the boot. This study could provide a new method to treat persistent diabetic foot wounds by enhancing blood circulation through transcutaneous electrical stimulation. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could lead to new treatment options for diabetic foot wounds.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for increasing blood flow in people with diabetes?

Research has shown that transcutaneous electrical stimulation (TENS) is generally safe. Various studies have used TENS to help manage diabetes symptoms, such as nerve pain. Although more research is needed in humans, animal studies suggest it might safely lower blood sugar levels. Other studies have found that similar treatments are well-tolerated and can relieve pain without major side effects. However, because these studies often involve small groups and short time frames, further research is necessary to confirm its safety for long-term use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Electrical Stimulation is unique because it offers a non-invasive way to enhance blood flow at the foot, especially crucial for people with diabetes. Unlike traditional diabetes treatments, which mainly focus on glucose control through medication or insulin, this method directly targets blood circulation using electrical impulses. Researchers are excited about this approach because it could potentially improve blood perfusion without the need for drugs, offering a new avenue for managing complications related to diabetes.

What evidence suggests that this electrical stimulation is effective for increasing blood flow in people with diabetes?

Research has shown that a device called TENS, which sends small electrical pulses through the skin, might help heal foot sores caused by diabetes. A review of several studies found that TENS can speed up the healing of these sores. Other studies have also found that TENS can reduce pain from nerve damage due to diabetes. Participants using TENS reported feeling less pain and noticed their sores healed faster. This trial will specifically investigate the effects of TENS on blood flow in the foot with the application of heat and electrical stimulation, suggesting that TENS might improve blood flow and aid the healing process in feet affected by diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Massood Atashbar, PhD

Principal Investigator

Western Michigan University

Are You a Good Fit for This Trial?

This trial is for individuals with and without diabetes to explore if a combination of electrical stimulation (TENS) and controlled heat can increase blood flow to the foot. It's especially aimed at helping those with diabetic wounds that are hard to heal.

Inclusion Criteria

My diabetes is under control with an HbA1c of 7% or less.

I am between 45 and 75 years old.

I have been diagnosed with Type I or Type II diabetes.

Exclusion Criteria

Pregnancy

Current smoker

Allergy to tape or electrodes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Measurement

Participants sit comfortably while baseline temperature, SPO2, and heart rate are measured

5 minutes

1 visit (in-person)

Treatment

Application of controlled heat and electrical stimulation to the foot to measure blood perfusion

30 minutes

1 visit (in-person)

Post-Treatment Measurement

Final measurement of blood perfusion after turning off heat and electrical stimulation

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Stimulation

Trial Overview The study is testing whether TENS combined with controlled heat in a boot device can improve foot blood flow more than just baseline conditions or heat alone, which could benefit people suffering from poor circulation due to diabetes.

How Is the Trial Designed?

Group I: Blood perfusion Experimental Treatment 1 Intervention

Blood flow at the foot with the application of heat and electrical stimulation

Who Is Running the Clinical Trial?

Western Michigan University

Lead Sponsor

Trials

18

Recruited

2,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9615295/

The effects of electrical stimulation on diabetic ulcers of foot ... Both studies conducted by Asadi et al , using DC showed statistically significant improvement in terms of HR in ischaemic DFUs after 4 weeks of intervention, ...

2. bmcendocrdisord.biomedcentral.com bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-022-01029-z

Effect of electrical stimulation on patients with diabetes-related ... A recent meta-analysis showed that ES may be an effective adjunctive therapy for accelerating diabetes-related foot ulceration healing [11].

3. nature.com nature.com/articles/s41598-020-75922-9

Non-invasive neuromodulation effects on painful diabetic ... They found that TENS therapy significantly improved generally neuropathic pain symptoms in the treatment of symptomatic DPN (ES = − 1.01, 95% CI ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20510476/

Effect of transcutaneous electrical nerve stimulation on ... TENS therapy was associated with significantly subjective improvement in overall neuropathic symptoms in 12 weeks follow-up [WMD-0.18, 95% CI (-0.32, -0.051)].

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iwj.70104

Electrical stimulation as an adjunctive therapy for diabetic ... Our systematic evaluation and meta-analysis demonstrated that ES treatment significantly improved the healing rate of DUs and the number of healed ulcers ...

6. nature.com nature.com/articles/s41598-023-29791-7

A randomized trial on the effect of transcutaneous electrical ... The results indicated that TENS could reduce FPG and HbA1c and was safe in animal models. However, current data in humans are scarce. The effect ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032S189B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The safety and effectiveness of the Abbott implantable neurostimulation system to treat DPN was based primarily on a systematic review of published scientific ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1871402125000402

A systematic review and meta-analysis of randomized ... We hypothesize that FREMS is an effective and safe non-pharmacological intervention for managing DPN, providing significant pain relief and potential ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07109895

Custom Insole With Transcutaneous Electrical Nerve ... Study Details | NCT07109895 | Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers | ClinicalTrials.gov.