Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

NCT ID: NCT01175928

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-09-30

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.

Conditions

Diabetic Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Peristaltic Pulse PCD

Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD)

Group Type: EXPERIMENTAL

NormaTec PCD (Peristaltic Pulse PCD)

Intervention Type: DEVICE

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

Sham Device

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

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: DEVICE

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

Interventions

Sham device

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

Intervention Type: DEVICE

NormaTec PCD (Peristaltic Pulse PCD)

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

Intervention Type: DEVICE

Other Intervention Names

NormaTec PCD (sham device); NormaTec PCD

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

NormaTec Industries LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Spirito, MD

Role: PRINCIPAL_INVESTIGATOR

Saints Medical Center

Locations

NormaTec

Newton Center, Massachusetts, United States

Countries

United States

Other Identifiers

1R43DK088634-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NormaTec_90513134-01

Identifier Type: -

Identifier Source: org_study_id