An Evaluation of an SCCD on the Symptomatology of Painful DPN

A Randomized Controlled Evaluation of the Effect of Sequential Contraction Compression Device on the Symptomatology of Painful Diabetic Neuropathy (PDN)

This is a controlled trial to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Subjects will be evaluated for Subjective Pain levels, quality of life, breakthrough drug use, sleep levels, and objectively with a Quantitative Sensory Testing device. The trial duration is 30 days.

Study Overview

• Status: Unknown
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Device: Flowaid FA-100 SCCD

Detailed Description

This is a controlled trial of 30 days duration to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will have to have been on a sustained drug regimen for more than 30 days and have an average pain level of 4 on a VAS. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Patients will be asked to use the SCCD device daily on both their legs. Subjects will be evaluated for Subjective Pain levels using a Visual Analog Scale, quality of life using various questionnaires, breakthrough drug use in a daily log, sleep levels i.e. how many consecutive hours of sleep, and objectively with a Quantitative Sensory Testing device.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Rosenblum, DPM; Phone Number: 720-744-3222; Email: diabfootman@gmail.com
• Study Contact Backup: Name: Evan Renov; Email: clinicaltrials@flowaid.com

Study Locations

• United States
  • New Jersey
    • Lodi, New Jersey, United States, 07055
      • Recruiting
      • Sean D Rosenblum DPM
      • Contact: Jonathan Rosenblum, DPM; Phone Number: 720-744-3222; Email: diabfootman@gmail.com
      • Contact: Evan Renov; Email: clinicaltrials@flowaid.com
      • Principal Investigator: Sean Rosenblum, DPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a current diagnosis of Type I or Type II Diabetes Mellitus
• Have a documented diagnosis of Diabetic Peripheral Neuropathy by either their Primary Care Physician or other physician treating their condition made no less than 6 months prior to initiation of the study.
• Have been on stable pain medications (no change to type, dose or frequency) for at least 1 month prior to their entry into the study.Give appropriate written informed consent prior to participation in the study
• Be between 18 and 90 years of age, inclusive, on the day the Informed Consent Form is signed
• Have an average baseline VAS score of 4 or more as assessed during the week just prior to randomization
• Be in reasonable metabolic control, exhibited by HbA1C values of less than 12% as observed by serum test results obtained within 3 months prior to the Screening Visit
• Be willing to remain on the same pain medication regimen for the duration of the study
• If subject is of childbearing potential, she must be using an acceptable method of birth control. Women not of childbearing potential are defined as either surgically sterile or post-menopausal. Post-menopausal women are defined as those women with a documented menstruation cessation for 12 consecutive months prior to signing the Informed Consent Form.
• Subject and caregiver, if applicable, must be accessible and willing to comply with all requirements of the study protocol for the duration of the study.

Exclusion Criteria:

• Clinical evidence of compromised skin (e.g., wound, infection, gangrene) on the lower legs
• Active Charcot's foot on either limb
• Malnourished as evidenced by a pre-albumin of < 11 mg/dL
• Pregnancy or lactating
• Known history of alcohol or drug abuse within the previous one year
• Previous treatment with SCCD
• Elective osseous procedures performed to either foot 30 days prior to Screening visit
• Vascular procedures performed 30 days prior to Screening Visit
• History of poor compliance to medical treatment regimens
• Conditions that may severely compromise their ability to complete the study.
• Concomitant history of Peripheral Arterial disease with an ABI of <0.5
• Chronic pain due to an etiology other than diabetic neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; This group will continue with their current treatment regimen during the course of the study. They will be monitored with daily questionnaires, and at the end of trial visit will also undergo a QST evaluation.
Active Comparator: Active Treatment Group; This group will continue with their current treatment regimen during the course of the study. In addition they will be given an active intervention with the Flowaid FA-100 SCCD device to utilize at home daily. They will be monitored with daily questionnaires, and at the end of trial visit will also undergo a QST evaluation.	Device: Flowaid FA-100 SCCD; The SCCD is a contained external non invasive electric muscle pump. The device attaches to the rear of the calf with 4 electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Subjective Pain	Reduction in pain as measured using a pain descriptive Visual Analog Scale (VAS). The SCCD treatment will be considered effective if the subjects treated with the SCCD demonstrate, on average, a 30% greater reduction in pain on the VAS as compared to the control subjects.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Sensation	1) The ability of the subject to discriminate temperature and vibration on the bottom of the foot as measured by a quantitative tool.	30 days
Analgesic Use	4) Improvement in PDN as measured by the change in usage of prescribed regimented and breakthrough medications for analgesia	30 days
Quality of Life	3) Improved quality of life as measured using the SF36 QOL questionnaire.	30 days

Collaborators and Investigators

• Sponsor: Rosenblum, Jonathan I., DPM

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies
• Other Study ID Numbers: SCN-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data will be shared with other investigators. Data sent to the data assessor will be anonymous.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No