A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain|
- VAS of pain
- SF36 for life quality
- sleep quality
- blood flow of feet
|Study Start Date:||June 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: Botulinum Toxin Type A
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336349
|Taipei, Taiwan, 106|
|Principal Investigator:||Chaur-Jong Hu, MD||Department of Neurology, Taipei Medical University Hospital, Taipei, Taiwan|