Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

Diabetic Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01175928
• Other study ID #: NormaTec_90513134-01
• Secondary ID: 1R43DK088634-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 3, 2010
• Last updated: April 18, 2012
• Start date: October 2010
• Est. completion date: September 2012

Study information

• Verified date: April 2012
• Source: NormaTec Industries LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

Device:
• Sham device
Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
• NormaTec PCD (Peristaltic Pulse PCD)
Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day

Locations

Country	Name	City	State
United States	NormaTec	Newton Center	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
NormaTec Industries LP	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve Conduction Studies	Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).	3 months	No
Primary	Nerve Conduction Studies	Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).	1 month	No
Primary	Nerve Conduction Studies	Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).	2 months	No
Secondary	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.	baseline; 1 month; 2 months; 3 months	No
Secondary	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)	baseline; 1 month; 2 months; 3 months	No