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Topical Menthol +/- Mannitol for Painful Diabetic Peripheral Neuropathy

NCT02728687 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-03-02

No results posted yet for this study

Summary

Treatments for painful diabetic peripheral neuropathy (PDPN) are not very effective and have multiple side effects. To find out if a menthol cream alone or with added mannitol treats PDPN effectively, 90 participants with PDPN, after one month of observation, will receive randomly assigned menthol cream or the same cream with mannitol added for 3 months with a crossover for 3 additional months. At time 0, 1,4 and 7 months their BPI pain severity and interference scores, DN4 scores, cream % effectiveness and side effects will be compared.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DRUG

Mannitol

Apply cream as needed up to 4 times daily to the painful foot and leg

DRUG

Menthol

Apply cream as needed up to 4 times daily to the painful foot and leg

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2020-03-30
Completion
2020-12-18

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02728687 on ClinicalTrials.gov