Scientific Evidence

Clinical Trial

  • A non randomized clinical trial performed in 29 patients demonstrated significant improvements in the neuropathic pain. The effectiveness seems to be  far superior to those published on prescription drugs currently used to treat peripheral neuropathy. All these drugs have also significant side effects and complications, while no complication or side effect has thus far been reported with the PeriphEX treatment.


  • A small study performed on 7 patients using nanobubbled gel showed that the objective signs of neuropathy have decreased after 4 to 8 treatments, suggesting a potential regression of the neuropathic disease.


  • A multi-center observational study is on-going to provide stronger evidence of the efficacy of the product. 

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Feasibility Clinical Trial (completed October 2017)

Design: 

Single site study prospective non randomized clinical trial. (Dr. J. Lamour, Austin, Texas)
Population: 29 patients.
Peripheral neuropathy from all etiologies.
 

Treatment:

4 to 11 treatments consisting of 30 minutes foot bath in O2
and CO2 nanobubbled water.
 

Results:

No complication or adverse effect 

Pain improved 50% or more in 65% patients.  (This is significantly better than most prescription drugs on the market)

Mean pain improvement: 50% ±4%.

Many positive comments from patients:


  • “I have stopped Neurontin and my narcotics.” 
  • “I can feel the gas pedal and feel much more safe driving.” 
  • “I’m no longer waking up at night with burning pain.” 
  • “I feel more stable on my feet.” 
  • “My toes do not curl up as much as they were and are in better contact with the ground.” 
  • “I am better able to move my toes and they are not so stiff.”  

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Feasibility Clinical Trial Using Hydrogel Infused with Gas Nanobubbled Water

(Completed September 2018) 


Design: 

Single site study prospective non randomized clinical trial. (Dr. J. Lamour, Austin, Texas)   

Population: 7patients.  

Peripheral neuropathy from all etiologies.


Treatment: 

4 to 10 treatments utilizing hydrogel infused with O2 and CO2 nanobubbled water placed in a bootie for 20 minutes.


Results:

Subjective - Pain and Numbness improved similarly to previous study:

  • Tingling pain improved from 7.0 to 2.75 (60%) 
  • Numbness improved from 7.50 to 5.25 (30%) 

Objective - Score of the condition of the Neuropathy improved significantly:

  • Toronto Neuropathic Score (scale 0-30, 0 is normal, 12 is considered severe neuropathy) improved from 21.5 to 16.4 (24%) 
  • Semmes-Weinstein Monofilament test, a measurement of feet sensitivity to touch (scale 0-20, 20 is normal), improved from 4 to 9.86 (146%).  

Improvements on these 2 objective tests after 4 to 8 treatments show that the treatment does not only affect the pain, but it may also have some effects on the neuropathic disease, potentially affecting or reversing the evolution of the disease!

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Toronto Neuropathy Score

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 Toronto Neuropathic Score (scale 0-30, 0 is normal) improved from   

Improvement from 21.5 to 16.4 (24%)  

Semmes-Weinstein 5.07 Monofilament Examination

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Semmes-Weinstein Monofilament test improved from  4 to 9.86 (146%)      

Disclaimer

The statements made on this website have not been evaluated by the Food & Drug Administration. The FDA only evaluates foods and drugs, not General Wellness Products like these products. These products are not intended to diagnose, prevent, treat, or cure any disease.