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A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633086
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : March 12, 2015
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:
This is a randomized, double-blind, placebo-controlled, 2-period crossover, 12-week trial to be conducted in 50 subjects with painful diabetic neuropathy. The objective of this trial is to assess the safety and efficacy of NO gel, a NO donor, as compared with a placebo gel, in symptom relief of subjects with painful diabetic neuropathy.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: nitric oxide gel Drug: placebo gel Phase 2

Detailed Description:
Neuropathic pain is a common symptom of diabetic neuropathy, and predominantly involves the lower limbs. Current strategies for the management of painful diabetic neuropathy include improved glycemic control, use of analgesics and addition of tricyclic antidepressants and anticonvulsants. However, many patients experience unsatisfactory responses and some undesired side effects. Considerable evidence implicates impaired nitric oxide synthesis plays an important role in the pathogenesis of diabetic neuropathic pain. Several small studies have shown that topical nitroglycerin ointment has local vasodilating properties, and a previous study has demonstrated that isosorbide dinitrate in spray form as a nitric oxide donor relieved some neuropathic symptoms in patients with painful diabetic neuropathy. Based on the findings, the investigators hypothesize that nitric oxide gel could be used as an alternative pain-relieving agent for patients with resistant diabetic neuropathic pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
Study Start Date : July 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: nitric oxide gel
  1. st gel: sodium nitrites
  2. nd gel: maleic/ascorbic acids
Drug: nitric oxide gel
  1. st gel: sodium nitrites,BID local use X 28 days
  2. nd gel: maleic/ascorbic acids ,BID local use X 28 days

Placebo Comparator: Placebo gel
  1. st gel: phosphate-buffered saline
  2. nd gel: maleic/ascorbic acids
Drug: placebo gel
placebo gel,BID local use X 28 days

Primary Outcome Measures :
  1. Neuopathic Pain Scale [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. vascular duplex parameters [ Time Frame: 12 weeks ]
  2. the likelihood of reusing the nitric oxide gel recorded [ Time Frame: 12weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects>=30 and<=80 years of age.
  2. Subjects with type 1 or type 2 diabetes mellitus with painful diabetic neuropathy.
  3. Subjects without undergoing treatment for painful diabetic neuropathy or with treatment for at least 3 months but still presenting neuropathic pain prior to randomization.
  4. Subjects who are healthy without any serious diseases that require hospitalization during the study period.
  5. Subjects who are capable of understanding and having signed the Informed Consent Form after detailed description of the treatment procedures and potential risks and benefits.

Exclusion Criteria:

  1. Subjects with diagnosis of cancer and are still on active therapies.
  2. Subjects with diagnosis of an active disease (e.g. hyper-or-hypothyroidism, advanced chronic renal failure, severe anemia, liver cirrhosis, active infectious disease etc.) and are still under regular treatment for this disease
  3. Subjects with peripheral neuropathy caused by a known acute or chronic disease or injury
  4. Subjects who are on other medications with pharmacological actions that may lead to excessive formation of nitric oxide (e.g. sublingual nitroglycerin, sildanafil etc.) or may accentuate drug effects due to excessive formation of nitric oxide.
  5. Subjects with severe peripheral artery disease leading to absence of foot pulses.
  6. Subjects with erratic glycemic control (HbA1c 12).
  7. Subjects with an active foot ulceration or infection.
  8. Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.
  9. Subjects who have been enrolled into any clinical study in the preceding 3 months prior to randomization.
  10. Subjects with current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result
  11. Female subject of childbearing potential who is lactating or has positive urine pregnancy test at V0 or refuses to adop reliable method of contraception during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633086

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China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
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Principal Investigator: Ching-Chu Chen, M.D. China Medical University Hospital
Study Director: Ching-Chu Chen, M.D China Medical University Hospital
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Responsible Party: China Medical University Hospital Identifier: NCT01633086    
Other Study ID Numbers: DMR99-IRB-273
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents