Status:
COMPLETED
A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain
Lead Sponsor:
Taipei Medical University Hospital
Collaborating Sponsors:
Allergan
Conditions:
Diabetes Mellitus
Neuropathic Pain
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
Effective treatment of neuropathic foot pain in diabetic patients is very important to improve their quality of life. There are many medications used to reduce the diabetic neuropathic pain, including...
Detailed Description
Design: The present study is a single-center, randomized, double-blinded, cross-over study of BOTOX® in diabetic neuropathic foot pain. Pain Assessment: Subjective intensity of neuropathic pain was r...
Eligibility Criteria
Inclusion
- type 2 diabetes with medication for diabetes\> 3 years (established diagnosis, HbA1C\<10% )
- symptomatic polyneuropathy (stocking distribution and tingling pain)
- stable but not satisfactory effects of drugs for diabetic neuropathic foot pain (stable effects of medication for over 6 months)
- fitness of polyneuropathy on Nerve Conduction Velocity (NCV) criteria
- willing and able to give written informed consent.
- willing and able to complete the entire study course and comply with study directions.
Exclusion
- Injection not possible due to physiologic barriers.
- Subject is pregnant or lactating.
- Females of childbearing age who are not using a reliable method of avoiding pregnancy.
- Significant medical or psychiatric disease.
- Any condition that may put the subject at increased risk with exposure to BOTOX®, including
- diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- Acute medication overuse in the investigator's best judgment.
- Alcohol or drug abuse.
- Heavy smokers
- Infection or skin problems at any of the injection sites.
- Known allergy or sensitivity to the study medications or its components.
- Injections of anesthetics or steroids into the study targeted muscles within one month prior to the day of injection
- Concurrent participation in another clinical trial within 30 days of the beginning of this study.
- Previous use of botulinum toxin. (Types A or B)
- Profound atrophy or excessive weakness of the muscles in the target area(s) or injection.
- Evidence of peripheral artery occlusion
- Evidence of liver or renal function impairment
- Evidence old stroke
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00336349
Start Date
June 1 2006
End Date
December 1 2007
Last Update
July 26 2011
Active Locations (1)
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1
Chaur-Jong Hu
Taipei, Taiwan, 106