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An Evaluation of an SCCD on the Symptomatology of Painful DPN

Primary Purpose

Painful Diabetic Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flowaid FA-100 SCCD
Sponsored by
Rosenblum, Jonathan I., DPM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sean D Rosenblum DPMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Active Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2017
Last Updated
November 2, 2017
Sponsor
Rosenblum, Jonathan I., DPM
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1. Study Identification

Unique Protocol Identification Number
NCT03331614
Brief Title
An Evaluation of an SCCD on the Symptomatology of Painful DPN
Official Title
A Randomized Controlled Evaluation of the Effect of Sequential Contraction Compression Device on the Symptomatology of Painful Diabetic Neuropathy (PDN)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rosenblum, Jonathan I., DPM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be sequentially divided into a control group or an active treatment group.
Masking
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.
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Active Treatment Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Flowaid FA-100 SCCD
Intervention Description
The SCCD is a contained external non invasive electric muscle pump. The device attaches to the rear of the calf with 4 electrodes.
Primary Outcome Measure Information:
Title
Reduction in Subjective Pain
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Quantitative Sensation
Description
1) The ability of the subject to discriminate temperature and vibration on the bottom of the foot as measured by a quantitative tool.
Time Frame
30 days
Title
Analgesic Use
Description
4) Improvement in PDN as measured by the change in usage of prescribed regimented and breakthrough medications for analgesia
Time Frame
30 days
Title
Quality of Life
Description
3) Improved quality of life as measured using the SF36 QOL questionnaire.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Rosenblum, DPM
Phone
720-744-3222
Email
diabfootman@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Renov
Email
clinicaltrials@flowaid.com
Facility Information:
Facility Name
Sean D Rosenblum DPM
City
Lodi
State/Province
New Jersey
ZIP/Postal Code
07055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Rosenblum, DPM
Phone
720-744-3222
Email
diabfootman@gmail.com
First Name & Middle Initial & Last Name & Degree
Evan Renov
Email
clinicaltrials@flowaid.com
First Name & Middle Initial & Last Name & Degree
Sean Rosenblum, DPM

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared with other investigators. Data sent to the data assessor will be anonymous.

Learn more about this trial

An Evaluation of an SCCD on the Symptomatology of Painful DPN

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