An Evaluation of an SCCD on the Symptomatology of Painful DPN
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|ClinicalTrials.gov Identifier: NCT03331614|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Painful Diabetic Neuropathy||Device: Flowaid FA-100 SCCD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be sequentially divided into a control group or an active treatment group.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The data collected by the investigator will be submitted to the assessor without indication of which group is active and which is control.|
|Official Title:||A Randomized Controlled Evaluation of the Effect of Sequential Contraction Compression Device on the Symptomatology of Painful Diabetic Neuropathy (PDN)|
|Actual Study Start Date :||October 15, 2017|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||April 30, 2018|
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.
Device: 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.
- Reduction in Subjective Pain [ Time Frame: 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.
- Quantitative Sensation [ Time Frame: 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.
- Analgesic Use [ Time Frame: 30 days ]4) Improvement in PDN as measured by the change in usage of prescribed regimented and breakthrough medications for analgesia
- Quality of Life [ Time Frame: 30 days ]3) Improved quality of life as measured using the SF36 QOL questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331614
|Contact: Jonathan Rosenblum, DPMfirstname.lastname@example.org|
|Contact: Evan Renovemail@example.com|
|United States, New Jersey|
|Sean D Rosenblum DPM||Recruiting|
|Lodi, New Jersey, United States, 07055|
|Contact: Jonathan Rosenblum, DPM 720-744-3222 firstname.lastname@example.org|
|Contact: Evan Renov email@example.com|
|Principal Investigator: Sean Rosenblum, DPM|