Status:
UNKNOWN
An Evaluation of an SCCD on the Symptomatology of Painful DPN
Lead Sponsor:
Rosenblum, Jonathan I., DPM
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18-90 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03331614
Start Date
October 15 2017
End Date
April 30 2018
Last Update
November 6 2017
Active Locations (1)
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1
Sean D Rosenblum DPM
Lodi, New Jersey, United States, 07055