Back to results

Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Polyneuropathy

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sham device

NormaTec PCD (Peristaltic Pulse PCD)

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring Diabetic polyneuropathy, Pneumatic Compression Device

Eligibility Criteria

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

Inclusion Criteria:

Patient diagnosed with type 1 or type 2 diabetes
Patient diagnosed with distal symmetric polyneuropathy (DPN) attributable to diabetes
A1C ≤ 11%
Abnormal peroneal motor nerve conduction study where CMAP amplitude is less than 4 mV bilaterally.

Exclusion Criteria:

Refuses consent
Unlikely to be compliant with the research protocol as judged by the clinical investigator
Neuropathy documented to be caused by something other than diabetes
Medication for neuropathic pain initiated within the previous 3 months (to avoid confounding the results of the study)
Medication for glucose control changed within the previous 3 months (to avoid confounding the results of the study)
Documented DVT within the previous 3 months (since an acute DVT is a contraindication for Pneumatic Medicine treatment)
Significant hepatic disease as judged by the clinical investigator (that might cause neuropathy unrelated to diabetes)
Documented cancer treatment within the past 5 years (that might cause neuropathy unrelated to diabetes)
History of exposure to neurotoxins or heavy metals (that might cause neuropathy unrelated to diabetes)
Documented alcohol or drug abuse (that might cause neuropathy unrelated to diabetes)
Documented major psychiatric disorder (that could contribute to non-adherence to the protocol)
Presence of a major lower extremity amputation (since unable to perform bilateral distal sensory perception testing of the feet and NCS on the peroneal motor nerve)
Significant peripheral arterial disease defined as an ankle-brachial index ("ABI") < 0.6 (to avoid critical limb ischemia and thus the high likelihood of the patient requiring a major amputation in the near future with drop out from the study)
Severe lower extremity edema as judged by the clinical investigator (in order to not confound the results)
End stage DPN where the peroneal motor nerve conduction results of both legs show an Amplitude = 0 mV
Currently participating in another clinical trial

Sites / Locations

NormaTec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Peristaltic Pulse PCD

Sham Device

Arm Description

Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD)

Sham Pneumatic Compression Device (looks and sounds like real device, but applies no compression)

Outcomes

Primary Outcome Measures

Nerve Conduction Studies

Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).

Nerve Conduction Studies

Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).

Nerve Conduction Studies

Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).

Secondary Outcome Measures

Sensory perception measurements

Non-invasive sensory perception will be assessed with a 10-g monofilament (pressure); a 128 Hz tuning fork and a Neurothesiometer (vibration); a toothpick (sharp sensation); a cotton ball (soft sensation); an iced tuning fork (cold sensation); and calculation of the Neuropathy Disability Score.

Quality of life questionnaires

The following questionnaires will be self-administered: Norfolk Quality-of-Life Questionnaire for Diabetic Neuropathy (QOL-DN); Neuropathy Total Symptom Score-6 (NTSS-6); Problem Areas in Diabetes (PAID)

Full Information

NCT ID

NCT01175928

First Posted

August 3, 2010

Last Updated

April 18, 2012

Sponsor

NormaTec Industries LP

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01175928

Brief Title

Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

Official Title

Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NormaTec Industries LP

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the treatment of Diabetic Peripheral Neuropathy (DPN). The study will compare treatment with a NormaTec PCD and a sham device to assess whether the NormaTec PCD improves the signs and symptoms of DPN.

Detailed Description

Diabetes frequently leads to decreased sensation in the legs caused by diabetic peripheral neuropathy (DPN). DPN is an important risk factor for the development of foot ulceration, one of the most common causes for hospital admissions and lower-limb amputations among diabetic patients. However, to date there are no medications currently approved by the Food and Drug Administration to treat DPN. The goal of this research project is to assess the effectiveness of a non-invasive, patented peristaltic pulse pneumatic compression device (the NormaTec PCD) in a home treatment program to improve the symptoms of DPN (e.g. numbness, pain, and tingling in the legs) and the underlying functioning of the nerves in the legs (as determined by sensory perception assessments and Nerve Conduction Studies testing). In this prospective, randomized, double-blind study, subjects will be randomly placed in one of two groups: a control group using a sham NormaTec PCD ("placebo"); and an experimental group using a NormaTec PCD.

6. Conditions and Keywords

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

Diabetic Polyneuropathy

Keywords

Diabetic polyneuropathy, Pneumatic Compression Device

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peristaltic Pulse PCD

Arm Type

Experimental

Arm Description

Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD)

Arm Title

Sham Device

Arm Type

Sham Comparator

Arm Description

Sham Pneumatic Compression Device (looks and sounds like real device, but applies no compression)

Intervention Type

Device

Intervention Name(s)

Sham device

Other Intervention Name(s)

NormaTec PCD (sham device)

Intervention Description

Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day

Intervention Type

Device

Intervention Name(s)

NormaTec PCD (Peristaltic Pulse PCD)

Other Intervention Name(s)

NormaTec PCD

Intervention Description

Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day

Primary Outcome Measure Information:

Title

Nerve Conduction Studies

Description

Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).

Time Frame

3 months

Title

Nerve Conduction Studies

Description

Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).

Time Frame

1 month

Title

Nerve Conduction Studies

Description

Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Sensory perception measurements

Description

Time Frame

baseline; 1 month; 2 months; 3 months

Title

Quality of life questionnaires

Description

Time Frame

baseline; 1 month; 2 months; 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient diagnosed with type 1 or type 2 diabetes Patient diagnosed with distal symmetric polyneuropathy (DPN) attributable to diabetes A1C ≤ 11% Abnormal peroneal motor nerve conduction study where CMAP amplitude is less than 4 mV bilaterally. Exclusion Criteria: Refuses consent Unlikely to be compliant with the research protocol as judged by the clinical investigator Neuropathy documented to be caused by something other than diabetes Medication for neuropathic pain initiated within the previous 3 months (to avoid confounding the results of the study) Medication for glucose control changed within the previous 3 months (to avoid confounding the results of the study) Documented DVT within the previous 3 months (since an acute DVT is a contraindication for Pneumatic Medicine treatment) Significant hepatic disease as judged by the clinical investigator (that might cause neuropathy unrelated to diabetes) Documented cancer treatment within the past 5 years (that might cause neuropathy unrelated to diabetes) History of exposure to neurotoxins or heavy metals (that might cause neuropathy unrelated to diabetes) Documented alcohol or drug abuse (that might cause neuropathy unrelated to diabetes) Documented major psychiatric disorder (that could contribute to non-adherence to the protocol) Presence of a major lower extremity amputation (since unable to perform bilateral distal sensory perception testing of the feet and NCS on the peroneal motor nerve) Significant peripheral arterial disease defined as an ankle-brachial index ("ABI") < 0.6 (to avoid critical limb ischemia and thus the high likelihood of the patient requiring a major amputation in the near future with drop out from the study) Severe lower extremity edema as judged by the clinical investigator (in order to not confound the results) End stage DPN where the peroneal motor nerve conduction results of both legs show an Amplitude = 0 mV Currently participating in another clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Spirito, MD

Organizational Affiliation

Saints Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

NormaTec

City

Newton Center

State/Province

Massachusetts

ZIP/Postal Code

02459

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

We'll reach out to this number within 24 hrs