Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02728687
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2016-03-30
Brief Title:
Topical Menthol - Mannitol for Painful Diabetic Peripheral Neuropathy
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Double Blind Randomized Crossover Study of Efficacy and Safety of Topical Menthol With and Without Mannitol in the Treatment of Painful Diabetic Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 14 and 7 months their BPI pain severity and interference scores DN4 scores cream effectiveness and side effects will be compared
Detailed Description:
Purpose to find out if a menthol cream containing mannitol is more effective than the same cream without mannitol in relieving painful diabetic peripheral neuropathy PDPN The test cream which will at a later date be marketed as QR cream contains Water Mannitol Propylene glycol Isopropyl palmitate Caprylic capric triglyceride Ceteareth 20 Cetearyl alcohol Glyceryl stearate Polyethylene glycol 100 Stearate Dimethicone Octyldodecanol Menthol Lecithin Ethylhexyl glycerin Phenoxyethanol The control cream contains the same ingredients minus the mannitol
Hypothesis a menthol cream containing mannitol is more effective at relieving the pain the physical limitations and the emotional distress caused by PDPN than the same cream without mannitol
Justification PDPN is common and can be disabling because of the intensity of the pain it can cause Less than 50 of those suffering from this condition get adequate pain relief from their current medications The oral medications anticonvulsants antidepressants NSAIDS marijuana derivatives and narcotics have numerous side effects and are potentially addictive Topical local anaesthetics have short-lived effect over only a small area and topical capsaicin often causes burning on application and prolonged use destroys the affected nerves A previous study has demonstrated mannitols effectiveness in down regulating the capsaicin receptor which is believed to cause the burning sensation of PDPN A cream containing mannitol has few side effects and if effective may decrease the need for other more dangerous medications
Objectives to show that a menthol cream containing mannitol is more effective over a period of 28 weeks than the same cream without mannitol at relieving the pain the physical limitations and the emotional distress caused by PDPN
Research Design this is a randomized double-blind placebo-controlled crossover trial involving 3 visits
Participants who are taking medications or insulin to treat diabetes will have onoff vibration test on the hallux of each foot If at least 5 of their 8 vibration tests are erroneous or I dont know their score on the DN4 questionnaire is 410 they will be enrolled
After 1 months observation period 90 participants will be given either a menthol cream with mannitol or the same cream without mannitol to apply to their feet for 3 months following which the creams will be crossed over for an additional 3 months Which cream is to be applied in the first 3 months will be chosen at random Participants and clinicians will be blinded as to cream assignment for the duration of the study Participants will be instructed to rub the cream on their feet and the tender nerves supplying their feet 2 to 4 times daily as needed for pain relief
At 014 and 7 month their BPI pain severity and interference scores DN4 scores cream effectiveness and side effects will be recorded At 4 and 7 months they will be compared
Statistical Analysis primary endpoint BPI pain interference scores how much pain interferes with function and relationships t-tests will compare the difference between the maximum daily pain interference score for the menthol cream as compared with the mannitol and menthol cream at 4 and 7 months Secondary endpoints BPI pain severity score and DN4 score how many symptoms of peripheral neuropathy are registered cream effectiveness incidence of side effects
Hypothesis a menthol cream containing mannitol is more effective at relieving the pain the physical limitations and the emotional distress caused by PDPN than the same cream without mannitol
Justification PDPN is common and can be disabling because of the intensity of the pain it can cause Less than 50 of those suffering from this condition get adequate pain relief from their current medications The oral medications anticonvulsants antidepressants NSAIDS marijuana derivatives and narcotics have numerous side effects and are potentially addictive Topical local anaesthetics have short-lived effect over only a small area and topical capsaicin often causes burning on application and prolonged use destroys the affected nerves A previous study has demonstrated mannitols effectiveness in down regulating the capsaicin receptor which is believed to cause the burning sensation of PDPN A cream containing mannitol has few side effects and if effective may decrease the need for other more dangerous medications
Objectives to show that a menthol cream containing mannitol is more effective over a period of 28 weeks than the same cream without mannitol at relieving the pain the physical limitations and the emotional distress caused by PDPN
Research Design this is a randomized double-blind placebo-controlled crossover trial involving 3 visits
Participants who are taking medications or insulin to treat diabetes will have onoff vibration test on the hallux of each foot If at least 5 of their 8 vibration tests are erroneous or I dont know their score on the DN4 questionnaire is 410 they will be enrolled
After 1 months observation period 90 participants will be given either a menthol cream with mannitol or the same cream without mannitol to apply to their feet for 3 months following which the creams will be crossed over for an additional 3 months Which cream is to be applied in the first 3 months will be chosen at random Participants and clinicians will be blinded as to cream assignment for the duration of the study Participants will be instructed to rub the cream on their feet and the tender nerves supplying their feet 2 to 4 times daily as needed for pain relief
At 014 and 7 month their BPI pain severity and interference scores DN4 scores cream effectiveness and side effects will be recorded At 4 and 7 months they will be compared
Statistical Analysis primary endpoint BPI pain interference scores how much pain interferes with function and relationships t-tests will compare the difference between the maximum daily pain interference score for the menthol cream as compared with the mannitol and menthol cream at 4 and 7 months Secondary endpoints BPI pain severity score and DN4 score how many symptoms of peripheral neuropathy are registered cream effectiveness incidence of side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None