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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00336349
First received: June 12, 2006
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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 Intervention
Diabetes Mellitus
Neuropathic Pain
Drug: Botulinum Toxin Type A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain

Resource links provided by NLM:


Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • VAS of pain

Secondary Outcome Measures:
  • SF36 for life quality
  • sleep quality
  • blood flow of feet

Enrollment: 30
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Botulinum Toxin Type A
    Botulinum Toxin Type A
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)

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336349

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

No publications provided

Responsible Party: Chaur-Jong Hu, Department of Neurology, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT00336349     History of Changes
Other Study ID Numbers: TMUH20060504
Study First Received: June 12, 2006
Last Updated: July 25, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University Hospital:
diabetes mellitus
neuropathic pain

Additional relevant MeSH terms:
Diabetes Mellitus
Neuralgia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014