Nociceptive Pain Fiber Response

January 10, 2018 updated by: Regenesis Biomedical, Inc.

A Multi-Center, Randomized, Sham-Controlled, Double-Blind Study of Pulsed Electromagnetic Field (PEMF) Therapy to Evaluate Small Fiber Nerve Growth and Function in Subjects With Painful Peripheral Diabetic Neuropathy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is multi-site, randomized, double-blind, sham-controlled study of the safety and efficacy of multi-dose Provant therapy to evaluate neuronal and vascular response in the treatment of subjects with painful peripheral diabetic neuropathy. Subjects will be randomized in a 2:1 ratio to receive therapy with an active device or an identical inactive sham device. Subjects will treat at home twice daily for 60 days after which they will return to the clinic for final evaluations. Subjects will be evaluated at the research center for a Baseline/Enrollment visit and again at Day 61 where assessments for safety, concomitant medications, Sympathetic Skin Response (SSR), Nerve Conduction Velocity (NCV), Skin Perfusion Pressures (SPP), and Skin Biopsy will be completed. Subjects will be contacted via telephone at Day 14, Day 28 and Day 42 to assess adherence, safety, and concomitant medications. Subjects will also complete a Response to Study Device form which will capture their daily pain score.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Extremity Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 has an HgbA1c > 7% and < 10%.
  4. 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.
  5. Subject is in pain Phase 2, 3, or 4 (Appendix C).
  6. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol including diary entries.
  7. 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).

Exclusion Criteria:

  1. Subject has Type 1 diabetes.
  2. Subject is in pain Phase 1 or 5 (Appendix C).
  3. Subject has an active, open ulcer on either lower extremity of arterial, venous or mixed disease origin.

  4. 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.

  5. 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.
  6. Subject has undergone decompression surgery on the index foot to treat peripheral neuropathy within 2 years of the Screening Visit.
  7. Subject requires or anticipates the need for surgery of any type during the 60 day treatment period.
  8. Subject is a smoker or has been a smoker within one year of the Screening Visit.
  9. Subject has a total foot thickness (plantar surface to mid-dorsal surface) of > 6 centimeters.
  10. Subject anticipates travelling over the course of the 60 day treatment period.
  11. 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.
  12. 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.
  13. Subject has used systemic corticosteroids within 2 months of the Screening Visit.
  14. 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.
  15. Subject has a history of malignancy within the past five years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area and/or localized in situ carcinoma of the cervix.
  16. Subject has a serious psychosocial co-morbidity.
  17. Subject has a history of drug or alcohol abuse, as confirmed by urine drug screen, within one year prior to the Screening Visit.
  18. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
  19. Subject is currently pregnant or planning on becoming pregnant prior to Day 60.
  20. Subject has been previously treated with the PROVANT Therapy System.
  21. Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Sham of Provant
Device: Provant Therapy System
OTHER: Active Treatment
Active Provant Treatment
Device: Provant Therapy System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60
Time Frame: 60 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regenesis Biomedical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBI.2015.002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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