An Evaluation of an SCCD on the Symptomatology of Painful DPN

Status unconfirmed · Not applicable

Conditions studied: Painful Diabetic Neuropathy

In brief

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.

Key facts

Study ID

NCT03331614

Run by

Rosenblum, Jonathan I., DPM

People needed

45

Starts

2017-10-15

Expected to finish

2018-04-30

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Sean D Rosenblum DPM — Lodi, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.