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

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: NCT00336349
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : July 26, 2011
Information provided by:
Taipei Medical University Hospital

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 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Neuropathic Pain Drug: Botulinum Toxin Type A Not Applicable

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 rated by a 100 mm visual analogue scale (VAS, 0 = no pain, 100 = unbearable pain). To assess the somatosensory effect of botulinum toxin, we also performed aserial somatosensory evaluations upon bilateral medial (L5 dermatome) and lateral (S1 dermatome) dorsum of the feet, and bilateral medial calves (L4 dermatome). Tactile threshold (TT) values of were assessed by von Frey filament, applied in an ascending and descending order of magnitude. The force required to bend the filaments was converted to log units for further comparison. Pain threshold (PT) to static mechanical stimuli was also determined by von Frey filament upon the above test sites to evaluate the severity of cutaneous allodynia. All subjects underwent the subjective pain rating and somatosensory evaluations (TT and PT) at baseline and each follow-up stage.

Treatment: Treatments will consist of intradermal (i.d). injections of BOTOX® after topical anesthesia over randomly selected 15 patients and saline placebo over the other 15 patients. Dose will be 0.5-1U/cm2 BOTOX®, at total dose of 50 U/foot. A follow-up visit and assessment will be performed at 1, 4 8, 12 weeks following treatment during which the previous tests will be repeated. A cross-over of injection in the Botox group and saline group will be taken at the 12th week and then repeat the assessments at 1, 4, 8, 12 weeks.

Analysis: Comparison between treated feet and non-treated feet based on QVAS and pain sensitivity test and life quality questionnaire by chi-square analysis.

The summary of proposal is as below. Botox: 1. intradermal injection after Topical anesthesia, EMLA 2. 1 cc syringe with 30-gauge needle 3. 50 U/foot 4. 12 points/foot (3×4) A total of 30 cases (15 Botox group, 15 saline group and cross-over 12 weeks later)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain
Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Foot Health

Intervention Details:
  • Drug: Botulinum Toxin Type A
    Botulinum Toxin Type A

Primary Outcome Measures :
  1. VAS of pain

Secondary Outcome Measures :
  1. SF36 for life quality
  2. sleep quality
  3. blood flow of feet

Information from the National Library of Medicine

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

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

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): NCT00336349

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Chaur-Jong Hu
Taipei, Taiwan, 106
Sponsors and Collaborators
Taipei Medical University Hospital
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Principal Investigator: Chaur-Jong Hu, MD Department of Neurology, Taipei Medical University Hospital, Taipei, Taiwan

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Responsible Party: Chaur-Jong Hu, Department of Neurology, Taipei Medical University Hospital Identifier: NCT00336349     History of Changes
Other Study ID Numbers: TMUH20060504
First Posted: June 13, 2006    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011
Keywords provided by Taipei Medical University Hospital:
diabetes mellitus
neuropathic pain
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents