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Trial record 1 of 1 for:    flowaid | Recruiting, Not yet recruiting Studies
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An Evaluation of an SCCD on the Symptomatology of Painful DPN

This study is currently recruiting participants.
Verified October 2017 by Rosenblum, Jonathan I., DPM
Sponsor:
ClinicalTrials.gov Identifier:
NCT03331614
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rosenblum, Jonathan I., DPM
  Purpose
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.

Condition Intervention
Painful Diabetic Neuropathy Device: Flowaid FA-100 SCCD

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be sequentially divided into a control group or an active treatment group.
Masking: Single (Outcomes Assessor)
Masking Description:
The data collected by the investigator will be submitted to the assessor without indication of which group is active and which is control.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Evaluation of the Effect of Sequential Contraction Compression Device on the Symptomatology of Painful Diabetic Neuropathy (PDN)

Resource links provided by NLM:


Further study details as provided by Rosenblum, Jonathan I., DPM:

Primary Outcome Measures:
  • Reduction in Subjective Pain [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures:
  • Quantitative Sensation [ Time Frame: 30 days ]
    1) The ability of the subject to discriminate temperature and vibration on the bottom of the foot as measured by a quantitative tool.

  • Analgesic Use [ Time Frame: 30 days ]
    4) Improvement in PDN as measured by the change in usage of prescribed regimented and breakthrough medications for analgesia

  • Quality of Life [ Time Frame: 30 days ]
    3) Improved quality of life as measured using the SF36 QOL questionnaire.


Estimated Enrollment: 45
Actual Study Start Date: October 15, 2017
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331614


Contacts
Contact: Jonathan Rosenblum, DPM 720-744-3222 diabfootman@gmail.com
Contact: Evan Renov clinicaltrials@flowaid.com

Locations
United States, New Jersey
Sean D Rosenblum DPM Recruiting
Lodi, New Jersey, United States, 07055
Contact: Jonathan Rosenblum, DPM    720-744-3222    diabfootman@gmail.com   
Contact: Evan Renov       clinicaltrials@flowaid.com   
Principal Investigator: Sean Rosenblum, DPM         
Sponsors and Collaborators
Rosenblum, Jonathan I., DPM
  More Information

Responsible Party: Rosenblum, Jonathan I., DPM
ClinicalTrials.gov Identifier: NCT03331614     History of Changes
Other Study ID Numbers: SCN-1
First Submitted: October 27, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared with other investigators. Data sent to the data assessor will be anonymous.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pain
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases