A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can treat diabetes. Study Design This is a randomized, double-blind, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in treating diabetes. Approximately 46 volunteers will participate in the study. Study Randomization The biostatistician will prepare a randomization schedule including a serial of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. This phase lasts for 4 weeks. At the end of Week 4, the active devices will replace the placebo. Both groups will be actively participating in the study for 2 months (8 weeks). Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number. The Principal Investigator, study physicians, study nurses, data-entry specialists, and biostatisticians, as well as the participants, will be blinded about who received which product during the first two weeks of study participation. Study Enrollment Each potentially qualified volunteer will review the Informed Consent Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discuss the e-ICF and e-Criteria with the study team medical professional via telephone during the scheduled time. Each qualified volunteer will sign the e-ICF and send it to the Medical Office Coordinator. The study coordinator will assign the qualified volunteer a randomized subject number, then the volunteer will become a study participant.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Willing and able to give informed consent for participation in the trial.

• Is able and willing to comply with all trial requirements.

• Male or female aged 18-70 years old without major diseases.

• An adult clinically diagnosed with DM2

• Participants must not be heavy users of Tesla BioHealing devices; enrollment will be determined by the clinical team based on an evaluation of the participant's prior device usage.

• Must be fluent in English.

Locations
United States
Florida
Tesla BioHealing Medical Center in Butler-FL
RECRUITING
Tampa
Pennsylvania
Tesla BioHealing Medical Center in Butler-PA
RECRUITING
Butler
Contact Information
Primary
Mariola A Smotrys, Principal Investigator, MD, MBA, MSc
mariola.smotrys@firstammmed.org
302-300-3010
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 46
Treatments
Placebo_comparator: Placebo
The same size, shape, and weight of the devices without emitting biophotons will be provided and used during the first 4 weeks of the randomized study period.
Experimental: Treatment
Eight Tesla Biophotonizer-A will be packed in 4 sleeves and used during the study. The Placebo will be packed the same way without emitting biophotons.
Related Therapeutic Areas
Sponsors
Leads: First Institute of All Medicines

This content was sourced from clinicaltrials.gov