A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 anticonvulsants, anti-depressants or analgesics, but none is universally satisfied. A few previous studies employing BOTOX® i.d. injection for control of trigeminal neuralgia, post-herpes neuralgia indicate that BOTOX® was effective in controlling neuropathic pain. Intradermal injection of BOTOX® to the dorsum of the foot in diabetics should be effective in controlling diabetes-associated polyneuropathic pain of the foot.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Medical University Hospital
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

1. type 2 diabetes with medication for diabetes> 3 years (established diagnosis, HbA1C<10% )

2. symptomatic polyneuropathy (stocking distribution and tingling pain)

3. stable but not satisfactory effects of drugs for diabetic neuropathic foot pain (stable effects of medication for over 6 months)

4. fitness of polyneuropathy on Nerve Conduction Velocity (NCV) criteria

5. willing and able to give written informed consent.

6. willing and able to complete the entire study course and comply with study directions.

Exclusion Criteria:

1. Injection not possible due to physiologic barriers.

2. Subject is pregnant or lactating.

3. Females of childbearing age who are not using a reliable method of avoiding pregnancy.

4. Significant medical or psychiatric disease.

5. Any condition that may put the subject at increased risk with exposure to BOTOX®, including

6. diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.

7. Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.

8. Acute medication overuse in the investigator's best judgment.

9. Alcohol or drug abuse.

10. Heavy smokers

11. Infection or skin problems at any of the injection sites.

12. Known allergy or sensitivity to the study medications or its components.

13. Injections of anesthetics or steroids into the study targeted muscles within one month prior to the day of injection

14. Concurrent participation in another clinical trial within 30 days of the beginning of this study.

15. Previous use of botulinum toxin. (Types A or B)

16. Profound atrophy or excessive weakness of the muscles in the target area(s) or injection.

17. Evidence of peripheral artery occlusion

18. Evidence of liver or renal function impairment

19. Evidence old stroke