Plantar FascitisPhase 4XeominNCT01678001
Treatment of Plantar Fasciitis With Xeomin
A Phase 4 study testing Xeomin in people with Plantar Fascitis, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of the foot. Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain. The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Xeomin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be adults above the age of 18 years of any gender or race.
- Subjects' diagnosis will be plantar fasciitis.
- Subjects should have attempted 6 weeks of nonsurgical treatment and failed prior to injection.
Who cannot join
- Subjects must not have a normal plantar fascia.
- Subjects must not have received previous BoTox injections at their plantar fascia.
- Subjects must have not have received prior surgery on their plantar fascia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Institute Orthopaedics
Philadelphia, Pennsylvania, 19107
About this study
Official title: Treatment of Plantar Fasciitis With Xeomin: A Randomized, Placebo-Controlled, Double-Blinded, Prospective Study
The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of the foot.
Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.
Read more
The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Surgical treatment of plantar fasciitis is indicated only if nonsurgical means fail.
A newer method of treating plantar fasciitis before resorting to surgery is the use of Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the subject to date. The purpose of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded study.
Read the detailed description
The plantar fascia is an inelastic, broad band of muscle on the plantar or undersurface of the foot. It runs from the plantar surface of the calcaneus or heel bone to the plantar surface of all 5 toes. The plantar fascia maintains the arch shape of the plantar foot. It also helps with shock absorption upon weight bearing activities such as walking and running.
Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain. This inflammation is often caused by over activity, improper shoes, flat feet, or excessive weight on the feet.
The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Such methods include daily stretching of the fascia, foot orthotics or inserts to provide arch support, night splinting, and shock-wave therapy. Surgical treatment of plantar fasciitis is indicated only if nonsurgical means fail. However, surgery does have risks, which include but are not limited to bleeding, infection, and nerve injury.
A newer method of treating plantar fasciitis before resorting to surgery is the use of Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Xeomin can only be delivered via direct injection into the targeted muscle. It takes effect in 2 to 3 days and generally lasts up to 3 to 6 months. Some doctors give Xeomin injections every 3 months or longer for treating spastic muscles. However, others provide single injections to help achieve a specific goal.
Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the subject to date. Much of the existing research involves BoTox A and non-controlled studies with less than 1 year of patient follow-up. To date, there is only 1 placebo-controlled, randomized, double-blinded study regarding BoTox A to treat plantar fasciitis. However, this study limits its follow-up to 8 weeks. The purpose of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded study.
- Conditions
- Plantar Fascitis
- Being tested
- Xeomin
- Keywords
- plantar fascia, plantar fascitis, botulinum toxin, Xeomin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeominDrug
Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.
| Study group | Role | What they receive |
|---|---|---|
| Xeomin | Active comparator | Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily. Receives: Drug: Xeomin |
| Placebo | Placebo comparator | Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily. Receives: Drug: Xeomin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
Function will be scored primarily according to the Foot and Ankle Ability Measure (FAAM), which is validated and reproducible. Scores are based on standing, walking, and performing activities of daily living (ADLs). The scores are between 0 points for being completely disabled and 100 points for being totally without symptoms. A score of 90 or more indicates an excellent result. The PI will gather scores before and after injection. These FAAM scores will be gathered at the time of outpatient follow-up and used to evaluate the final outcome.
Measured: 1 year
Secondary outcomes (1)
Pain
Patients' pain will be scored with a 10 cm visual analog scale (VAS). If applicable, progression to surgical treatment will also be documented.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Principal investigator, Jamal Ahmad, Rothman Institute Orthopaedics
- Investigators
- Jamal Ahmad, M.D., Principal investigator, Rothman Institute Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678001
- Sponsor's protocol ID
- MRZ IIT - 2011 - 009
- Acronym
- Xeomin
- Status last verified
- Jan 2017
- First submitted
- 30 Aug 2012
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Plantar Fasciitis With Xeomin: A Randomized, Placebo-Controlled, Double-Blinded, Prospective Study
- ClinicalTrials.gov ID
- NCT01678001
- Acronym / sponsor ID
- Xeomin / MRZ IIT - 2011 - 009
- Conditions
- Plantar Fascitis
- Keywords
- plantar fascia, plantar fascitis, botulinum toxin, Xeomin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- Aug 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Sep 2012 (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 plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of the foot.
Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.
The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Surgical treatment of plantar fasciitis is indicated only if nonsurgical means fail.
A newer method of treating plantar fasciitis before resorting to surgery is the use of Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the subject to date. The purpose of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded study.
Detailed description
The plantar fascia is an inelastic, broad band of muscle on the plantar or undersurface of the foot. It runs from the plantar surface of the calcaneus or heel bone to the plantar surface of all 5 toes. The plantar fascia maintains the arch shape of the plantar foot. It also helps with shock absorption upon weight bearing activities such as walking and running.
Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain. This inflammation is often caused by over activity, improper shoes, flat feet, or excessive weight on the feet.
The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Such methods include daily stretching of the fascia, foot orthotics or inserts to provide arch support, night splinting, and shock-wave therapy. Surgical treatment of plantar fasciitis is indicated only if nonsurgical means fail. However, surgery does have risks, which include but are not limited to bleeding, infection, and nerve injury.
A newer method of treating plantar fasciitis before resorting to surgery is the use of Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Xeomin can only be delivered via direct injection into the targeted muscle. It takes effect in 2 to 3 days and generally lasts up to 3 to 6 months. Some doctors give Xeomin injections every 3 months or longer for treating spastic muscles. However, others provide single injections to help achieve a specific goal.
Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the subject to date. Much of the existing research involves BoTox A and non-controlled studies with less than 1 year of patient follow-up. To date, there is only 1 placebo-controlled, randomized, double-blinded study regarding BoTox A to treat plantar fasciitis. However, this study limits its follow-up to 8 weeks. The purpose of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xeomin | Active comparator | Drug: XeominGroup A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily. |
| Placebo | Placebo comparator | Drug: XeominGroup B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be adults above the age of 18 years of any gender or race.
- Subjects' diagnosis will be plantar fasciitis.
- Subjects should have attempted 6 weeks of nonsurgical treatment and failed prior to injection.
Key exclusion criteria (3 listed)
- Subjects must not have a normal plantar fascia.
- Subjects must not have received previous BoTox injections at their plantar fascia.
- Subjects must have not have received prior surgery on their plantar fascia.
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 |
|---|---|---|
| XeominGroup A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily. | Drug | Placebo, Xeomin |
Primary outcome
Function
Time frame: 1 year
Function will be scored primarily according to the Foot and Ankle Ability Measure (FAAM), which is validated and reproducible. Scores are based on standing, walking, and performing activities of daily living (ADLs). The scores are between 0 points for being completely disabled and 100 points for being totally without symptoms. A score of 90 or more indicates an excellent result. The PI will gather scores before and after injection. These FAAM scores will be gathered at the time of outpatient follow-up and used to evaluate the final outcome.
1 secondary outcome
Pain
Time frame: 1 year
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 18 Jan 2017.
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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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.
Jamal Ahmad, M.D. principal investigator
Rothman Institute Orthopaedics
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 Xeomin in people with Plantar Fascitis, run by Rothman Institute Orthopaedics at 1 site in United States.
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 3 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 18 Jan 2017. 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 United States. 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?
Function (time frame: 1 year). 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 18 Jan 2017.