Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336349
Status:
COMPLETED
Last Update Posted:
2011-07-26
First Post:
2006-06-12
Brief Title:
A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain
Sponsor:
Taipei Medical University Hospital
Organization:
Taipei Medical University Hospital
Study Overview
Official Title:
A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 id 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
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 id injections of BOTOX after topical anesthesia over randomly selected 15 patients and saline placebo over the other 15 patients Dose will be 05-1Ucm2 BOTOX at total dose of 50 Ufoot 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 Ufoot 4 12 pointsfoot 34 A total of 30 cases 15 Botox group 15 saline group and cross-over 12 weeks later
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 id injections of BOTOX after topical anesthesia over randomly selected 15 patients and saline placebo over the other 15 patients Dose will be 05-1Ucm2 BOTOX at total dose of 50 Ufoot 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 Ufoot 4 12 pointsfoot 34 A total of 30 cases 15 Botox group 15 saline group and cross-over 12 weeks later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None