An Evaluation of an SCCD on the Symptomatology of Painful DPN

Not Applicable

• Conditions: Painful Diabetic Neuropathy
• Interventions: Device: Flowaid FA-100 SCCD

• Registration Number: NCT03331614
• Lead Sponsor: Rosenblum, Jonathan I., DPM

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.

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 Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-15
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment Group	Flowaid FA-100 SCCD	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.

Primary Outcome Measures

Name	Time	Method
Reduction in Subjective Pain	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

Name	Time	Method
Quality of Life	30 days	3) Improved quality of life as measured using the SF36 QOL questionnaire.
Analgesic Use	30 days	4) Improvement in PDN as measured by the change in usage of prescribed regimented and breakthrough medications for analgesia
Quantitative Sensation	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.

Trial Locations

Locations (1)

Sean D Rosenblum DPM; 🇺🇸 Lodi, New Jersey, United States