Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy

NCT03077893 | Completed Results FDA Device

• 1 other identifier: RBI.2017.001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• Vibration Perception Threshold (VPT)

  A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy

  Baseline to End of Treatment (Day 121)

• Quantitative Sensory Testing (QST)

  QST is a noninvasive test used in peripheral nervous system disorders for thermal sensory testing.

  Baseline to End of Treatment (Day 121)

Secondary Outcomes (9)

• Nerve Conduction Velocity (NCV) - Velocity

  The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).

• Skin Perfusion Pressures (SPP)

  SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).

• Pain Intensity (PI)

  Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91

• Brief Pain Inventory (BPI); Question on Pain Right Now.

  Change in BPI, pain right now question, from Baseline to Day 121.

• Brief Fatigue Inventory (BFI)

  Change from Baseline to Day 121 in BFI.

Study Arms (2)

Active Group

EXPERIMENTAL

Treatment with active Provant Therapy System

Device: Active Provant Therapy System

Sham Group

SHAM COMPARATOR

Treatment with Inactive (sham) Provant Therapy System

Device: Inactive (sham) Provant Therapy System

Interventions

Active Provant Therapy System DEVICE

Treatment with active Provant Therapy System

Active Group

Inactive (sham) Provant Therapy System DEVICE

Treatment with Inactive (sham) Provant Therapy System

Sham Group

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 1 or Type 2 diabetes mellitus (receiving insulin, diet controlled, or taking parenteral hypoglycemic agents)
• Subject is on a stable antidiabetic regimen (medication and/or diet) to control their diabetes for at least 30 days prior to Screening.
• Subject has an HbA1c \<10% at Screening or within 2 months of Screening.
• Subject has daily pain attributed to bilateral symmetrical Diabetic Peripheral Neuropathy with numbness, tingling, and/or burning based on clinical judgement for at least 6 months prior to screening.
• Subject's pain or discomfort from DPN is identifiable.
• Subject is in pain Phase 2, 3, or 4 as per the Phasing of Neuropathy Scale.
• Subjects average pain over the last 24 hours is ≥3 based on the 11-point Numeric Pain Rating Scale (NPRS) at the Screening Visit.
• Subject has adequate lower extremity pulse in both feet and no intermittent claudication.
• Subject is able to ambulate independently without assistive devices.
• 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 agrees 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 is in pain Phase 1 or 5 as per the Phasing of Neuropathy Scale.
• Subject has an active, open ulcer on the lower extremities.
• Subject has peripheral vascular disease defined as absence of more than one foot pulse per foot and/or ABI \<0.8 and \>1.4 and/or history of angioplasty or peripheral bypass surgery within 6 months of the Screening Visit.
• Subject has venous insufficiency as classified by the Venous Insufficiency Classification System of grade C6.
• Subject has undergone nerve decompression surgery on the lower extremities.
• Subject has a history of previous kidney, pancreas, cardiac transplantation, or severe renal disease.
• Subject has been diagnosed with non-diabetic chronic inflammatory neuropathic disease (e.g. end stage renal disease, hepatitis C, chemotherapy induced neuropathy, known connective tissue disease, systemic lupus).
• Subject has peripheral vascular disease requiring revascularization of lower limb or amputation or evidence of ulcer amputation.
• Subject has clinically significant cardiovascular disease within 6 months prior to screening (unstable or poorly controlled hypertension, transient ischemic attack, MI, unstable angina, arrhythmia, any heart surgery, stent placement, heart disease).
• Subject has a history of any uncontrolled medical illness that in the Investigators judgment places the subject at unacceptable risk for receipt of PEMF therapy.
• Subject requires or anticipates the need for surgery of any type or travel during the treatment period.
• Subject has a total foot depth (most inferior aspect of the medial malleolus to the plantar aspect of the foot when residing on a treatment pad) of \>8 cm.
• Subject has received any investigational drug or device 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 3 months of the Screening Visit.
• Subject has a history of malignancy within the past 5 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.

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (1)

Associated Foot & Ankle Specialists, LLC

Phoenix, Arizona, 85015, United States

Location

Results Point of Contact

• Title: Heather M Vander Ploeg
• Organization: Regenesis Biomedical

heather.vanderploeg@regenesisbio.com

602-428-7041

Study Officials

• Arthur Tallas, DPM

  Associated Foot & Ankle Specialists, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham devices will look identical to active devices. This is a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects deemed "responders" after active treatment will be randomized in a 1:1 ratio to either active treatment or a sham device.

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 13, 2017
• Study Start: March 9, 2017
• Primary Completion: December 26, 2017
• Study Completion: December 26, 2017
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)