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A Study to Evaluate PEMF Therapy on Experimentally Inducted Pain in Subjects With Painful Peripheral Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT02809911
Recruitment Status : Completed
First Posted : June 22, 2016
Results First Posted : February 13, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Regenesis Biomedical, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Painful Peripheral Diabetic Neuropathy
Intervention: Device: Provant

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.

Reporting Groups
  Description
Sham of Provant

Sham of Provant Therapy System

Provant

Active Provant

Active Provant Treatment

Provant


Participant Flow:   Overall Study
    Sham of Provant   Active Provant
STARTED   22 [1]   19 [1] 
COMPLETED   22 [2]   19 [2] 
NOT COMPLETED   0   0 
[1] This is the Initial Treatment Population (subjects that started the Enrollment Visit / Visit 2)
[2] This is the Initial Treatment Population (subjects that completed the Enrollment Visit / Visit 2)



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sham of Provant

Sham of Provant Therapy System

Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.

Active Provant

Active Provant Treatment

Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.

Total Total of all reporting groups

Baseline Measures
   Sham of Provant   Active Provant   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   19   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (12.14)   63.8  (12.38)   63.4  (12.10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  63.6%      9  47.4%      23  56.1% 
Male      8  36.4%      10  52.6%      18  43.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      11  50.0%      7  36.8%      18  43.9% 
Not Hispanic or Latino      11  50.0%      11  57.9%      22  53.7% 
Unknown or Not Reported      0   0.0%      1   5.3%      1   2.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   9.1%      3  15.8%      5  12.2% 
White      19  86.4%      16  84.2%      35  85.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   4.5%      0   0.0%      1   2.4% 
Region of Enrollment 
[Units: Participants]
     
United States   22   19   41 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.6  (4.89)   29.4  (5.17)   30  (5) 


  Outcome Measures

1.  Primary:   Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli   [ Time Frame: 4 weeks ]

2.  Primary:   Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Heather Vander Ploeg
Organization: Regenesis Biomedical
phone: 602-4287041
e-mail: Heather.VanderPloeg@regenesisbio.com



Responsible Party: Regenesis Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02809911     History of Changes
Other Study ID Numbers: RBI.2016.002
First Submitted: June 20, 2016
First Posted: June 22, 2016
Results First Submitted: October 26, 2016
Results First Posted: February 13, 2017
Last Update Posted: March 31, 2017