Topical Menthol +/- Mannitol for Painful Diabetic Peripheral Neuropathy

• Status: Completed
• Trial end date: 2020-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Mannitol; Menthol

Criteria

Inclusion Criteria:

• • 19 years of age or older

• Are currently being treated for diabetes with medications or insulin

• Suffering from painful diabetic peripheral neuropathy affecting their feet for at least three months.

• Maximum daily pain or discomfort score in each foot greater than or equal to 5/10.

• Score on the DN4 questionnaire at least 4/10

• At least 5 incorrect or I don't know responses to 8 on/off vibration tests

• Able and willing to attend Dr. Helene Bertrand's office three times.

Exclusion Criteria:

• • Known Allergies to any of the ingredients of the cream

• Open lesions diabetic foot ulcers or abrasions on the skin where the cream will be applied

• Unwilling to stop using other topical products (creams or patches) for the treatment of their neuropathic pain at least 14 days before joining this study.

• Pain in each foot which varies by more than 2/10 from day-to-day

• Pregnant (a urine pregnancy test will be done on women younger than 50 at their first visit )

• breast-feeding,

• Women of reproductive age and not using the following methods of contraception:

1. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (DepoProvera, Lunelle), or hormone implant (Norplant System)

2. Double-barrier method

3. Non-hormonal intrauterine devices

4. Vasectomy of partner

• Limited standing or walking from any cause (back, knees, feet, etc) other than diabetic neuropathic pain.

• Giving a history or exhibiting clinical signs of other causes of neuropathic pain such as spinal claudication, severe back pain on standing or walking, or a history of having received chemotherapy.

• Pain extending above the ankles.

• Those with ischemic peripheral vascular disease

• Those receiving acupuncture or using a TENS machine Those undergoing hydrotherapy

• Those who are unable to understand English, French, or Spanish and can not attend Dr. Bertrand's office with someone who will translate for them.