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Behavioural Intervention

Peristaltic Pulse PCD for Diabetic Polyneuropathy

Phase 1 & 2
Waitlist Available
Led By Nicholas Spirito, MD
Research Sponsored by NormaTec Industries LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 1 month; 2 months; 3 months
Awards & highlights

Study 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.

Eligible Conditions
  • Diabetic Polyneuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 1 month; 2 months; 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 1 month; 2 months; 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nerve Conduction Studies
Secondary outcome measures
Quality of life questionnaires
Sensory perception measurements

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Peristaltic Pulse PCDExperimental Treatment1 Intervention
Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD)
Group II: Sham DevicePlacebo Group1 Intervention
Sham Pneumatic Compression Device (looks and sounds like real device, but applies no compression)

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,014 Total Patients Enrolled
NormaTec Industries LPLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
Nicholas Spirito, MDPrincipal InvestigatorSaints Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy
2010. "Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01175928.
All > Neuropathy > Peripheral Neuropathy
~4 spots leftby Apr 2025
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