Nociceptive Pain Fiber Response

NCT02696070 | Completed Results

• 1 other identifier: RBI.2015.002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the effectiveness of the Provant Therapy System in improving localized nerve growth and skin perfusion in subjects with painful peripheral diabetic neuropathy of the foot.

Conditions

Painful Peripheral Diabetic Neuropathy

Keywords

Pain; Diabetic Neuropathy; Pulsed Electromagnetic Energy Field; PEMF; PPDN

Outcome Measures

Primary Outcomes (1)

• Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60

  The mean percent change in intraepidermal nerve fiber density mean values for mean nerve fibers per millimeter squared from baseline to Day 60 was calculated for each treatment group (value at 60 days minus value at baseline).

  60 days

Study Arms (2)

Sham of Provant

OTHER

Sham of Provant

Device: Provant Therapy System

Active Treatment

OTHER

Active Provant Treatment

Device: Provant Therapy System

Interventions

Provant Therapy System DEVICE

Active Treatment; Sham of Provant

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 has an HgbA1c \> 7% and \< 10%.
• Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or burning in at least one foot confirmed by a positive provocative sign and a positive Tinel's sign. If both feet are involved, the one with the greatest severity will be selected as the index foot.
• Subject is in pain Phase 2, 3, or 4 (Appendix C).
• Subject is willing and able to give written informed consent and to comply with all parts of the study protocol including diary entries.
• 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).

You may not qualify if:

• Subject has Type 1 diabetes.
• Subject is in pain Phase 1 or 5 (Appendix C).
• 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 \>1.40 or \< 0.80. See Appendix E for details on obtaining the ABI.
• NOTE: If the difference in the brachial pulse pressure between the right and left arms is \> 10 mmHg, the subject will not be eligible for enrollment and will be referred to a cardiologist for further evaluation.
• Subject has venous insufficiency classified by the Venous Insufficiency Classification System (CEAP) of grades C3, C4, C5, or C6. See Appendix F for description of the venous insufficiency grading.
• Subject has undergone decompression surgery on the index foot to treat peripheral neuropathy within 2 years of the Screening Visit.
• Subject requires or anticipates the need for surgery of any type during the 60 day treatment period.
• Subject is a smoker or has been a smoker within one year of the Screening Visit.
• Subject has a total foot thickness (plantar surface to mid-dorsal surface) of \> 6 centimeters.
• Subject anticipates travelling over the course of the 60 day treatment period.
• 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 undergone any local injection into the index foot within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
• Subject has used systemic corticosteroids within 2 months of the Screening Visit.
• Subject has a history of any uncontrolled medical illness that in the investigator's judgment places the subject at unacceptable risk for receipt of PEMF therapy.

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (1)

Extremity Health Center

Scottsdale, Arizona, 85260, United States

Location

MeSH Terms

Conditions

Pain; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Heather Vander Ploeg
• Organization: Regenesis Biomedical

heather.vanderploeg@regenesisbio.com

602-428-7041

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 2, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 12, 2018
• Results First Posted: January 12, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)