A Randomized, Sham-Controlled, Double-Blind, Crossover Study to Evaluate Pulsed Electromagnetic Field (PEMF) Therapy on Pain Sensitivity to Different Qualities of Experimentally Induced Pain in Subjects With Painful Peripheral Diabetic Neuropathy

Painful Peripheral Diabetic Neuropathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02809911
• Other study ID #: RBI.2016.002
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2016
• Last updated: October 3, 2016
• Start date: June 2016

Study information

• Verified date: October 2016
• Source: Regenesis Biomedical, Inc.
• Contact: Mark Davis
• Phone: 8779704970
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject age is greater than or equal to 22 years and less than 80 years of age.

2. Subject has documented Type 2 diabetes.

3. Subject's BMI = 38.

4. Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or burning in at least one foot.

5. Subject is in pain Phase 2, 3, or 4 (Appendix B).

6. 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).

7. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.

8. 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).

9. 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.

Exclusion Criteria:

1. Subject has current pain other than their painful peripheral diabetic neuropathy.

2. 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.

3. Subject has taken prescription opioids for their pain within 30 days of the Screening Visit or 6 weeks of Screening for long acting medications.

4. Subject has used topical capsaicin within 30 days of the Screening Visit.

5. Subject has Type 1 diabetes.

6. Subject is in pain Phase 1 or 5 (Appendix B).

7. Subject has an active, open ulcer on either lower extremity of arterial, venous or mixed disease origin.

8. 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.

9. 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.

10. Subject has an unhealed surgery on the legs, feet, arms or hands.

11. Subject has smoked within 4 hours of the Screening Visit.

12. 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.

13. Subject has used systemic corticosteroids within 2 months of the Screening Visit.

14. 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.

15. Subject has a serious psychosocial co-morbidity.

16. Subject has a self-reported history of drug or alcohol abuse, within one year prior to the Screening Visit.

17. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).

18. Subject is currently pregnant.

19. Subject has been previously treated with the PROVANT Therapy System within 30 days of the Enrollment Visit.

20. Subject is unwilling or unable to follow study instructions.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Peripheral Diabetic Neuropathy

Intervention

Device:
• Provant

Locations

Country	Name	City	State
United States	Sun Research Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Regenesis Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain sensitivity to various experimentally induced pain stimuli with reports of pain based on an 11 point scale.		4 weeks	No