Diabetes MellitusNCT00336349
A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain
A study testing Botulinum Toxin Type A in people with Diabetes Mellitus and Neuropathic Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Neuropathic Pain
- What is being tested?
- Botulinum Toxin Type A
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes with medication for diabetes> 3 years (established diagnosis, HbA1C<10% )
- symptomatic polyneuropathy (stocking distribution and tingling pain)
- stable but not satisfactory effects of drugs for diabetic neuropathic foot pain (stable effects of medication for over 6 months)
- fitness of polyneuropathy on Nerve Conduction Velocity (NCV) criteria
- willing and able to give written informed consent.
- willing and able to complete the entire study course and comply with study directions.
Who cannot join
- Injection not possible due to physiologic barriers.
- Subject is pregnant or lactating.
- Females of childbearing age who are not using a reliable method of avoiding pregnancy.
- Significant medical or psychiatric disease.
- Any condition that may put the subject at increased risk with exposure to BOTOX®, including
- diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
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- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- Acute medication overuse in the investigator's best judgment.
- Alcohol or drug abuse.
- Heavy smokers
- Infection or skin problems at any of the injection sites.
- Known allergy or sensitivity to the study medications or its components.
- Injections of anesthetics or steroids into the study targeted muscles within one month prior to the day of injection
- Concurrent participation in another clinical trial within 30 days of the beginning of this study.
- Previous use of botulinum toxin. (Types A or B)
- Profound atrophy or excessive weakness of the muscles in the target area(s) or injection.
- Evidence of peripheral artery occlusion
- Evidence of liver or renal function impairment
- Evidence old stroke
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Diabetes Mellitus, Neuropathic Pain
- Being tested
- Botulinum Toxin Type A
- Keywords
- diabetes mellitus, neuropathic pain
- Medical subject headings
- Diabetes Mellitus, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS of pain
Secondary outcomes (3)
SF36 for life quality
sleep quality
blood flow of feet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Chaur-Jong Hu, MD, Principal investigator, Department of Neurology, Taipei Medical University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336349
- Sponsor's protocol ID
- TMUH20060504
- Status last verified
- Jul 2011
- First submitted
- 12 Jun 2006
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain
- ClinicalTrials.gov ID
- NCT00336349
- Acronym / sponsor ID
- TMUH20060504
- Conditions
- Diabetes Mellitus, Neuropathic Pain
- Keywords
- diabetes mellitus, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- type 2 diabetes with medication for diabetes> 3 years (established diagnosis, HbA1C<10% )
- symptomatic polyneuropathy (stocking distribution and tingling pain)
- stable but not satisfactory effects of drugs for diabetic neuropathic foot pain (stable effects of medication for over 6 months)
- fitness of polyneuropathy on Nerve Conduction Velocity (NCV) criteria
- willing and able to give written informed consent.
Key exclusion criteria (19 listed)
- Injection not possible due to physiologic barriers.
- Subject is pregnant or lactating.
- Females of childbearing age who are not using a reliable method of avoiding pregnancy.
- Significant medical or psychiatric disease.
- Any condition that may put the subject at increased risk with exposure to BOTOX®, including
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type ABotulinum Toxin Type A | Drug | – |
Primary outcome
VAS of pain
3 secondary outcomes
SF36 for life quality
sleep quality
blood flow of feet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaur-Jong Hu, MD principal investigator
Department of Neurology, Taipei Medical University Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A in people with Diabetes Mellitus and Neuropathic Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS of pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.