Hallux ValgusPhase 4NCT01501500
Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole
A Phase 4 study testing BOTOX and Normal Saline (0.9% NaCl) in people with Hallux Valgus, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals and decrease the release of acetylcholine… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- BOTOX and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Aug 2013
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hallux valgus with angle of at least 20°,
- single or bilateral hallux valgus.
Who cannot join
- history of foot operations,
- rheumatoid arthritis and gouty arthritis.
- Any contraindication on BTA administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effect of Botulinum Toxin Type A in Addition to Total Contact Insole in Treating Painful Hallux valgus-a Pilot Study
The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of hallux valgus treated with total contact insole. The outcome measurement may shed light in treating patient with painful hallux valgus and document evidence for plantar pressure changes in acute, sub-acute and chronic stage.
Read the detailed description
This is a randomized, double-blind, placebo-controlled prospective study to assess the influence and efficacy of intramuscular (IM) Botulinum Toxin Type A (BTA) injection in patients with painful hallux valgus with the use of total contact insole.
Fifty feet with painful hallux valgus will be collected. Informed consent is obtained according to the hospital's medical ethics and the human clinical trial committee. The feet will be randomized into 2 groups: Group A (n=25, treatment group) and Group B (n=25, control group). Clinical diagnosis of hallux valgus is made based on observation of great toe lateral deviation. Inclusion criteria were hallux valgus with angle of at least 20°, single or bilateral hallux valgus. To obtain the hallux valgus angle, foot roentgenography in AP and sesamoid views under the weight bearing condition will be obtained. The angle formed by lines drawn to bisect the first metatarsal bone and the proximal phalanx of the great toe will be measured. The exclusion criteria include history of foot operations, rheumatoid and gouty arthritis, and any contraindication to BTA administration. Subjective data such as the Foot Function Index will be collected.
- Conditions
- Hallux Valgus
- Being tested
- BOTOX, Normal Saline (0.9% NaCl)
- Keywords
- botulinum toxin type A, hallux valgus angle, foot function index, VAS pain scale
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOXDrug
Also called BOTOX (Allergan, Irvine, CA)
once injection of BTA 3oU into hallux oblique and transverse heads each
Normal Saline (0.9% NaCl)Drug
Normal saline 0.3ml to oblique and transverse heads each
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin type A. HV angle | Active comparator | intramuscular injection of BTA into target muscle Receives: Drug: BOTOX |
| Normal saline, HV angle | Placebo comparator | intramuscular injection of normal saline into target muscle Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hallux valgus angle
radiological assessment before and after the intervention
Measured: up to 18 months
Secondary outcomes (1)
foot function index for quality of life
Foot Function Index before and after the intervention
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Katie P Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501500
- Sponsor's protocol ID
- NSC 99-2314-B-182A-020
- Status last verified
- Mar 2010
- First submitted
- 21 Dec 2011
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu KP, Chen CK, Lin SC, Pei YC, Lin RH, Tsai WC, Fuk-Tan Tang S. Botulinum Toxin type A injections for patients with painful hallux valgus: a double-blind, randomized controlled study. Clin Neurol Neurosurg. 2015 Feb;129 Suppl 1:S58-62. doi: 10.1016/S0303-8467(15)30014-7.
PubMed 25683315
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Botulinum Toxin Type A in Addition to Total Contact Insole in Treating Painful Hallux valgus-a Pilot Study
- ClinicalTrials.gov ID
- NCT01501500
- Acronym / sponsor ID
- NSC 99-2314-B-182A-020
- Conditions
- Hallux Valgus
- Keywords
- botulinum toxin type A, hallux valgus angle, foot function index, VAS pain scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Dec 2011 (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.
The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of hallux valgus treated with total contact insole. The outcome measurement may shed light in treating patient with painful hallux valgus and document evidence for plantar pressure changes in acute, sub-acute and chronic stage.
Detailed description
This is a randomized, double-blind, placebo-controlled prospective study to assess the influence and efficacy of intramuscular (IM) Botulinum Toxin Type A (BTA) injection in patients with painful hallux valgus with the use of total contact insole.
Fifty feet with painful hallux valgus will be collected. Informed consent is obtained according to the hospital's medical ethics and the human clinical trial committee. The feet will be randomized into 2 groups: Group A (n=25, treatment group) and Group B (n=25, control group). Clinical diagnosis of hallux valgus is made based on observation of great toe lateral deviation. Inclusion criteria were hallux valgus with angle of at least 20°, single or bilateral hallux valgus. To obtain the hallux valgus angle, foot roentgenography in AP and sesamoid views under the weight bearing condition will be obtained. The angle formed by lines drawn to bisect the first metatarsal bone and the proximal phalanx of the great toe will be measured. The exclusion criteria include history of foot operations, rheumatoid and gouty arthritis, and any contraindication to BTA administration. Subjective data such as the Foot Function Index will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin type A. HV angle | Active comparator | Drug: BOTOXintramuscular injection of BTA into target muscle |
| Normal saline, HV angle | Placebo comparator | Drug: Normal Saline (0.9% NaCl)intramuscular injection of normal saline into target muscle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hallux valgus with angle of at least 20°,
- single or bilateral hallux valgus.
Key exclusion criteria (3 listed)
- history of foot operations,
- rheumatoid arthritis and gouty arthritis.
- Any contraindication on BTA administration
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 |
|---|---|---|
| BOTOXAlso: BOTOX (Allergan, Irvine, CA)once injection of BTA 3oU into hallux oblique and transverse heads each | Drug | botulinum toxin type A. HV angle |
| Normal Saline (0.9% NaCl)Normal saline 0.3ml to oblique and transverse heads each | Drug | Normal saline, HV angle |
Primary outcome
hallux valgus angle
Time frame: up to 18 months
radiological assessment before and after the intervention
1 secondary outcome
foot function index for quality of life
Time frame: up to 18 months
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 6 Sep 2013.
- Derived from this study: PubMed 25683315Wu KP, Chen CK, Lin SC, Pei YC, Lin RH, Tsai WC, Fuk-Tan Tang S. Botulinum Toxin type A injections for patients with painful hallux valgus: a double-blind, randomized controlled study. Clin Neurol Neurosurg. 2015 Feb;129 Suppl 1:S58-62. doi: 10.1016/S0303-8467(15)30014-7.
Related trials for Hallux Valgus
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
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.
Katie P Wu, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BOTOX and Normal Saline (0.9% NaCl) in people with Hallux Valgus, run by Chang Gung Memorial 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 2 inclusion and 3 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 6 Sep 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
hallux valgus angle (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01501500, which also lists 1 linked publication.
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 6 Sep 2013.