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

NCT02809911 | Completed Results

• 1 other identifier: RBI.2016.002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity and nervous system response to various qualities of experimentally induced pain in the upper and lower extremities of subjects with painful peripheral diabetic neuropathy.

Conditions

Painful Peripheral Diabetic Neuropathy

Outcome Measures

Primary Outcomes (2)

• Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli

  Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored).

  4 weeks

• Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli

  Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). .

  4 weeks

Study Arms (2)

Sham of Provant

OTHER

Sham of Provant Therapy System

Device: Provant

Active Provant

OTHER

Active Provant Treatment

Device: Provant

Interventions

Provant DEVICE

Active Provant; Sham of Provant

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age is greater than or equal to 22 years and less than 80 years of age.
• Subject has documented Type 2 diabetes.
• Subject's BMI ≤ 38.
• Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or burning in at least one foot.
• Subject is in pain Phase 2, 3, or 4 (Appendix B).
• Subject is willing to forego smoking during the Enrollment Visit and Visit 3 (Crossover) for 4 hours prior to and through the duration of testing (\~5 hours).
• Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
• Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).
• Subject is able to eat in the morning prior to the induced pain tests and provide a meal/snacks for themselves during the day to maintain blood sugar levels.

You may not qualify if:

• Subject has current pain other than their painful peripheral diabetic neuropathy.
• Subject has a concomitant medical condition that, in the opinion of the investigator, would confound the ability to conduct induced pain testing in the upper and lower extremities.
• Subject has taken prescription opioids for their pain within 30 days of the Screening Visit or 6 weeks of Screening for long acting medications.
• Subject has used topical capsaicin within 30 days of the Screening Visit.
• Subject has Type 1 diabetes.
• Subject is in pain Phase 1 or 5 (Appendix B).
• Subject has an active, open ulcer on either lower extremity of arterial, venous or mixed disease origin.
• Subject has peripheral arterial disease as determined by an Ankle-Brachial Index (ABI) of \<0.5 or \> 1.4. See Appendix C for details on obtaining the ABI.
• Subject has venous insufficiency classified by the Venous Insufficiency Classification System (CEAP) of grade C6. See Appendix D for description of the venous insufficiency grading.
• Subject has an unhealed surgery on the legs, feet, arms or hands.
• Subject has smoked within 4 hours of the Screening Visit.
• Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.
• Subject has used systemic corticosteroids within 2 months of the Screening Visit.
• Subject has a history of a solid tumor that is not in complete remission for greater than 2 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area.
• Subject has a serious psychosocial co-morbidity.

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (2)

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Multi-Phase Trials, LLC

San Antonio, Texas, 78217, United States

Location

Results Point of Contact

• Title: Heather Vander Ploeg
• Organization: Regenesis Biomedical

Heather.VanderPloeg@regenesisbio.com

602-4287041

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 31, 2017
• Results First Posted: February 13, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)