Recruiting

SCCD

Sponsor:

Rosenblum, Jonathan I., DPM

Code:

NCT03331614

Conditions

Painful Diabetic Neuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Flowaid FA-100 SCCD

Study Details

Brief summary:

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.

Conditions

Painful Diabetic Neuropathy

Study ID

NCT03331614

Start date

Oct 15, 2017

Status verified date

Oct, 2017

Completion date

Apr 30, 2018

Anticipated

Primary completion date

Apr 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Reduction in Subjective Pain [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Jonathan Rosenblum, DPM

720-744-3222diabfootman@gmail.com

Evan Renov

clinicaltrials@flowaid.com

Locations

Sean D Rosenblum DPM

Recruiting

Lodi, New Jersey, United States, 07055

Contacts

Jonathan Rosenblum, DPM

720-744-3222diabfootman@gmail.com

Evan Renov

clinicaltrials@flowaid.com

Principal Investigator:

Sean Rosenblum, DPM

More Information

Sponsor

Rosenblum, Jonathan I., DPM

Last update posted

Nov 6, 2017

Last verified

Oct, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rosenblum, Jonathan I., DPM on 2017-11-06.