Diabetic Peripheral NeuropathyPhase 1/2NCT02728687
Topical Menthol +/- Mannitol for Painful Diabetic Peripheral Neuropathy
A Phase 1/2 study testing Mannitol and Menthol in people with Diabetic Peripheral Neuropathy, run by University of British Columbia at 5 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Mannitol and Menthol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Mar 2017to 18 Dec 2020
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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,
Show all 17Show fewer
- Women of reproductive age and not using the following methods of contraception:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (DepoProvera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Non-hormonal intrauterine devices
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Private Physician's Office
Courtenay, British Columbia, V9N 2P6
Okanagan Interventional Pain Clinic,
Kelowna, British Columbia, V1Y 4Z5
Suite 303 - 570 Raymer Avenue, Kelowna, BC, Canada, V1Y 4Z5
Nelson, British Columbia, V1L 4C6
Dr. Helene Bertrand Inc., 220-1940 Lonsdale Ave.
North Vancouver, British Columbia, V7M 2K2
Maple Tree Medical Clinic
Salmon Arm, British Columbia, V1E 2S5
About this study
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
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.
Read the 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 mannitol's 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 on/off vibration test on the hallux of each foot. If at least 5 of their 8 vibration tests are erroneous or "I don't know", their score on the DN4 questionnaire is >4/10 they will be enrolled.
After 1 month's 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 0,1,4 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Mannitol, Menthol
- Keywords
- peripheral neuropathy, Diabetes, Pain
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetes Mellitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Also called QR cream
Apply cream as needed up to 4 times daily to the painful foot and leg
MentholDrug
Apply cream as needed up to 4 times daily to the painful foot and leg
| Study group | Role | What they receive |
|---|---|---|
| Mannitol and menthol cream | Experimental | Mannitol and menthol cream (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) applied as needed, up to 4 times daily for one month, to the feet of a person suffering from painful diabetic peripheral neuropathy. During the other month, the menthol cream will be applied to the participant's feet. Whether the mannitol and menthol cream will be given in the first or the second month will be chosen at random. At the end of the 2 months, if the participant chooses this cream, they will be given 3 months' supply of the cream to apply as needed to both feet. Receives: Drug: Mannitol; Drug: Menthol |
| Menthol cream | Active comparator | Cream containing menthol (Water, Propylene glycol, Isopropyl palmitate. Caprylic capric triglyceride, Ceteareth 20, Cetearyl alcohol, Glyceryl stearate, Polyethylene glycol 100 Stearate, Dimethicone, Octyldodecanol, Menthol, Lecithin, Ethylhexyl glycerin, Phenoxyethanol) applied as needed, up to 4 times daily for one month, to the feet of a person suffering from painful diabetic peripheral neuropathy. During the other month, the mannitol and menthol cream will applied to the participant's feet. Whether the menthol cream will be given in the first or the second month will be chosen at random. At the end of the 2 months, if the participant chooses this cream, they will be given 3 months' supply of the cream to apply as needed to both feet. Receives: Drug: Menthol |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPI pain interference improvement 3 months
Compares the change in BPI pain interference score after 3 months of cream use for menthol and mannitol cream and menthol cream alone.
Measured: 3 month
Secondary outcomes (5)
Maximum BPI pain severity improvement 3 months
Compares the change in maximum BPI pain severity score after 3 months of cream use for menthol and mannitol cream and menthol cream alone.
Measured: 3 months
NH4 improvement 3 month
Compares the change in NH4 score after 3 months of cream use for menthol and mannitol cream and menthol cream alone.
Measured: 3 months
% improvement from cream use
Compares the % improvement from cream use after 3 months of cream use for menthol and mannitol cream and menthol cream alone.
Measured: 3 months
Satisfaction score
Compares the Satisfaction score from cream use after 3 months of cream use for menthol and mannitol cream and menthol cream alone.
Measured: 3 months
incidence of side effects
Compares the incidence of side effects from cream use after 3 months of cream use for menthol and mannitol cream and menthol cream alone.
Measured: 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 Apr 2016 (estimated)
- Study start15 Mar 2017
- Primary completion30 Mar 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Bertrand, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728687
- Sponsor's protocol ID
- M for PDPN
- Status last verified
- Feb 2021
- First submitted
- 30 Mar 2016
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, sex, pain medications used, brief pain inventory pain interference and pain severity scores (BPI), DN4 (neuropathy questionnaire), % effectiveness and side effects of cream. An encrypted, de-identified database containing this information will be shared with other researchers when the database is complete.
Publications
Bertrand H, Kyriazis M, Reeves KD, Lyftogt J, Rabago D. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial. PM R. 2015 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.
PubMed 25978942Daousi C, MacFarlane IA, Woodward A, Nurmikko TJ, Bundred PE, Benbow SJ. Chronic painful peripheral neuropathy in an urban community: a controlled comparison of people with and without diabetes. Diabet Med. 2004 Sep;21(9):976-82. doi: 10.1111/j.1464-5491.2004.01271.x.
PubMed 15317601Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993 Feb;36(2):150-4. doi: 10.1007/BF00400697.
PubMed 8458529Duby JJ, Campbell RK, Setter SM, White JR, Rasmussen KA. Diabetic neuropathy: an intensive review. Am J Health Syst Pharm. 2004 Jan 15;61(2):160-73; quiz 175-6. doi: 10.1093/ajhp/61.2.160.
PubMed 14750401Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728Perkins BA, Olaleye D, Zinman B, Bril V. Simple screening tests for peripheral neuropathy in the diabetes clinic. Diabetes Care. 2001 Feb;24(2):250-6. doi: 10.2337/diacare.24.2.250.
PubMed 11213874
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02728687
- Acronym / sponsor ID
- M for PDPN
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- peripheral neuropathy, Diabetes, Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 5 Apr 2016 (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.
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.
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 mannitol's 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 on/off vibration test on the hallux of each foot. If at least 5 of their 8 vibration tests are erroneous or "I don't know", their score on the DN4 questionnaire is >4/10 they will be enrolled.
After 1 month's 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 0,1,4 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol and menthol cream | Experimental | Drug: Mannitol, Drug: MentholMannitol and menthol cream (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) applied as needed, up to 4 times daily for one month, to the feet of a person suffering from painful diabetic peripheral neuropathy. During the other month, the menthol cream will be applied to the participant's feet. Whether the mannitol and menthol cream will be given in the first or the second month will be chosen at random. At the end of the 2 months, if the participant chooses this cream, they will be given 3 months' supply of the cream to apply as needed to both feet. |
| Menthol cream | Active comparator | Drug: MentholCream containing menthol (Water, Propylene glycol, Isopropyl palmitate. Caprylic capric triglyceride, Ceteareth 20, Cetearyl alcohol, Glyceryl stearate, Polyethylene glycol 100 Stearate, Dimethicone, Octyldodecanol, Menthol, Lecithin, Ethylhexyl glycerin, Phenoxyethanol) applied as needed, up to 4 times daily for one month, to the feet of a person suffering from painful diabetic peripheral neuropathy. During the other month, the mannitol and menthol cream will applied to the participant's feet. Whether the menthol cream will be given in the first or the second month will be chosen at random. At the end of the 2 months, if the participant chooses this cream, they will be given 3 months' supply of the cream to apply as needed to both feet. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • 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
Key exclusion criteria (17 listed)
- • 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 )
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 |
|---|---|---|
| MannitolAlso: QR creamApply cream as needed up to 4 times daily to the painful foot and leg | Drug | Mannitol and menthol cream |
| MentholApply cream as needed up to 4 times daily to the painful foot and leg | Drug | Mannitol and menthol cream, Menthol cream |
Primary outcome
BPI pain interference improvement 3 months
Time frame: 3 month
Compares the change in BPI pain interference score after 3 months of cream use for menthol and mannitol cream and menthol cream alone.
5 secondary outcomes
Maximum BPI pain severity improvement 3 months
Time frame: 3 months
NH4 improvement 3 month
Time frame: 3 months
% improvement from cream use
Time frame: 3 months
Satisfaction score
Time frame: 3 months
incidence of side effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Background: PubMed 25978942Bertrand H, Kyriazis M, Reeves KD, Lyftogt J, Rabago D. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial. PM R. 2015 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.
- Background: PubMed 15317601Daousi C, MacFarlane IA, Woodward A, Nurmikko TJ, Bundred PE, Benbow SJ. Chronic painful peripheral neuropathy in an urban community: a controlled comparison of people with and without diabetes. Diabet Med. 2004 Sep;21(9):976-82. doi: 10.1111/j.1464-5491.2004.01271.x.
- Background: PubMed 8458529Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993 Feb;36(2):150-4. doi: 10.1007/BF00400697.
- Background: PubMed 14750401Duby JJ, Campbell RK, Setter SM, White JR, Rasmussen KA. Diabetic neuropathy: an intensive review. Am J Health Syst Pharm. 2004 Jan 15;61(2):160-73; quiz 175-6. doi: 10.1093/ajhp/61.2.160.
- Background: PubMed 11690728Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Background: PubMed 11213874Perkins BA, Olaleye D, Zinman B, Bril V. Simple screening tests for peripheral neuropathy in the diabetes clinic. Diabetes Care. 2001 Feb;24(2):250-6. doi: 10.2337/diacare.24.2.250.
- Individual participant dataSharing planned: Yes. Age, sex, pain medications used, brief pain inventory pain interference and pain severity scores (BPI), DN4 (neuropathy questionnaire), % effectiveness and side effects of cream. An encrypted, de-identified database containing this information will be shared with other researchers when the database is complete.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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 Mannitol and Menthol in people with Diabetic Peripheral Neuropathy, run by University of British Columbia at 5 sites in Canada.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BPI pain interference improvement 3 months (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728687, which also lists 6 linked publications.
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 2 Mar 2021.