An Evaluation of an SCCD on the Symptomatology of Painful DPN

NCT03331614 | Unknown DMC FDA Device

• 1 other identifier: SCN-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quantitative Sensation

  30 days

• Analgesic Use

  30 days

• Quality of Life

  30 days

Study Arms (2)

Control Group

NO INTERVENTION

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 Treatment Group

ACTIVE COMPARATOR

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

Interventions

Flowaid FA-100 SCCD DEVICE

The SCCD is a contained external non invasive electric muscle pump. The device attaches to the rear of the calf with 4 electrodes.

Active Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rosenblum, Jonathan I., DPM: lead

Study Sites (1)

Sean D Rosenblum DPM

Lodi, New Jersey, 07055, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Jonathan Rosenblum, DPM

CONTACT

720-744-3222; diabfootman@gmail.com

Evan Renov

CONTACT

clinicaltrials@flowaid.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data collected by the investigator will be submitted to the assessor without indication of which group is active and which is control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: Subjects will be sequentially divided into a control group or an active treatment group.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 6, 2017
• Study Start: October 15, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)