Diabetic PolyneuropathyPhase 1/2NCT01175928
Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy
A Phase 1/2 study testing NormaTec PCD (Peristaltic Pulse PCD) in people with Diabetic Polyneuropathy, run by NormaTec Industries LP at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- NormaTec PCD (Peristaltic Pulse PCD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy
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.
Read the 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
- Being tested
- Sham device, NormaTec PCD (Peristaltic Pulse PCD)
- Keywords
- Diabetic polyneuropathy, Pneumatic Compression Device
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham deviceDevice
Also called NormaTec PCD (sham device)
Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
NormaTec PCD (Peristaltic Pulse PCD)Device
Also called NormaTec PCD
Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
| Study group | Role | What they receive |
|---|---|---|
| Peristaltic Pulse PCD | Experimental | Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD) Receives: Device: NormaTec PCD (Peristaltic Pulse PCD) |
| Sham Device | Sham comparator | Sham Pneumatic Compression Device (looks and sounds like real device, but applies no compression) Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Conduction Studies
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Measured: 3 months
Nerve Conduction Studies
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Measured: 1 month
Nerve Conduction Studies
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Measured: 2 months
Secondary outcomes (2)
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.
Measured: baseline; 1 month; 2 months; 3 months
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)
Measured: baseline; 1 month; 2 months; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NormaTec Industries LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Spirito, MD, Principal investigator, Saints Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175928
- Sponsor's protocol ID
- NormaTec_90513134-01
- Other IDs
- 1R43DK088634-01
- Status last verified
- Apr 2012
- First submitted
- 3 Aug 2010
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01175928
- Acronym / sponsor ID
- NormaTec_90513134-01
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Diabetic polyneuropathy, Pneumatic Compression Device
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NormaTec Industries LPIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peristaltic Pulse PCD | Experimental | Device: NormaTec PCD (Peristaltic Pulse PCD)Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD) |
| Sham Device | Sham comparator | Device: Sham deviceSham Pneumatic Compression Device (looks and sounds like real device, but applies no compression) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham deviceAlso: NormaTec PCD (sham device)Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day | Device | Sham Device |
| NormaTec PCD (Peristaltic Pulse PCD)Also: NormaTec PCDHome treatment with PCD to both legs: 2 sessions of 1 hour duration every day | Device | Peristaltic Pulse PCD |
Primary outcome
Nerve Conduction Studies
Time frame: 3 months
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Nerve Conduction Studies
Time frame: 1 month
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Nerve Conduction Studies
Time frame: 2 months
Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
2 secondary outcomes
Sensory perception measurements
Time frame: baseline; 1 month; 2 months; 3 months
Quality of life questionnaires
Time frame: baseline; 1 month; 2 months; 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Spirito, MD principal investigator
Saints Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NormaTec PCD (Peristaltic Pulse PCD) in people with Diabetic Polyneuropathy, run by NormaTec Industries LP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve Conduction Studies (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.