Plantar FasciitisPhase 2NCT03978234
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
A Phase 2 study testing AbobotulinumtoxinA 300 UNT in people with Plantar Fasciitis and Plantar Fasciitis, Chronic, run by University Foot and Ankle Foundation at 1 site in United States.
Trial summary
The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Fasciitis, Plantar Fasciitis, Chronic, Plantar Fasciitis of Both Feet
- What is being tested?
- AbobotulinumtoxinA 300 UNT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 31 Dec 2021
- Phase
- Phase 2
- 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
- At least 18 years old and not older than 75 years.
- History of Plantar fasciitis for a minimum of 6 weeks
- History and physical examination consistent with plantar fasciitis and a diagnostic ultrasound study showing thickening of the plantar fascia >5 mm (normal is 3 mm)
- Minimum Visual Analog Scale (VAS) score of 4.
- Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- Subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules.
Who cannot join
- Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf.
- Patients with no pain in the heel region.
- Subject is pregnant or breast- feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Foot & Ankle Institute
Santa Monica, California, 90403
Maha K. Curley, CRC, mahak@footanklesintitute.com
About this study
Official title: A Phase II Clinical Trial Evaluating the Safety and Effect of abobotulinumtoxinA Injection in the Gastrocnemius Muscle to Improve Equinus and Associated Plantar Fasciitis Pain
The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.
- Being tested
- AbobotulinumtoxinA 300 UNT
- Keywords
- Heel pain, Plantar Fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinA 300 UNTDrug
AbobotulinumtoxinA 300 UNT
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Single group Receives: Drug: AbobotulinumtoxinA 300 UNT |
What is being measured
The primary outcome is the main question the study is designed to answer.
injection
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection
Measured: 8 weeks
Secondary outcomes (8)
Adverse Events
Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection
Measured: 26 weeks
PROMIS Pain intensity instrument
Changes in PROMIS Pain Intensity Instrument,
Measured: 26 weeks
PROMIS Pain interference instrument
Changes in PROMIS Pain Interference Instrument
Measured: 26 weeks
PROMIS Physical function Instrument
Changes in PROMIS Physical function instrument
Measured: 26 weeks
AOFAS Ankle-Hindfoot Score
Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Measured: 26 weeks
FAAM Foot and Ankle Ability Measure
Changes in the Foot and Ankle Ability Measure
Measured: 26 weeks
Gastrocnemius measurement
Changes in gastrocnemius muscle size using ultrasonography
Measured: 26 weeks
Gastrocnemius measurement and mobility
Changes in gastrocnemius range of motion/dorsiflexion using goniometer
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start20 Nov 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Foot and Ankle Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha K. Curley, University Foot and Ankle Foundation
- Investigators
- Babak Baravarian, DPM, Principal investigator, University Foot & Ankle Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978234
- Sponsor's protocol ID
- UFAI-PF-01
- Status last verified
- Sep 2020
- First submitted
- 23 May 2019
- Last updated
- 24 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating the Safety and Effect of abobotulinumtoxinA Injection in the Gastrocnemius Muscle to Improve Equinus and Associated Plantar Fasciitis Pain
- ClinicalTrials.gov ID
- NCT03978234
- Acronym / sponsor ID
- UFAI-PF-01
- Keywords
- Heel pain, Plantar Fasciitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Foot and Ankle FoundationUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Jun 2019 (actual)
- 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 purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Drug: AbobotulinumtoxinA 300 UNTSingle group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old and not older than 75 years.
- History of Plantar fasciitis for a minimum of 6 weeks
- History and physical examination consistent with plantar fasciitis and a diagnostic ultrasound study showing thickening of the plantar fascia >5 mm (normal is 3 mm)
- Minimum Visual Analog Scale (VAS) score of 4.
- Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection.
Key exclusion criteria (3 listed)
- Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf.
- Patients with no pain in the heel region.
- Subject is pregnant or breast- feeding.
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 |
|---|---|---|
| AbobotulinumtoxinA 300 UNTAbobotulinumtoxinA 300 UNT | Drug | Single group |
Primary outcome
injection
Time frame: 8 weeks
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection
8 secondary outcomes
Adverse Events
Time frame: 26 weeks
PROMIS Pain intensity instrument
Time frame: 26 weeks
PROMIS Pain interference instrument
Time frame: 26 weeks
PROMIS Physical function Instrument
Time frame: 26 weeks
AOFAS Ankle-Hindfoot Score
Time frame: 26 weeks
FAAM Foot and Ankle Ability Measure
Time frame: 26 weeks
Gastrocnemius measurement
Time frame: 26 weeks
Gastrocnemius measurement and mobility
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Plantar Fasciitis
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
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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.
Babak Baravarian, DPM principal investigator
University Foot & Ankle Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AbobotulinumtoxinA 300 UNT in people with Plantar Fasciitis and Plantar Fasciitis, Chronic, run by University Foot and Ankle Foundation 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 7 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: status not confirmed, as of the sponsor's last update on 24 Sep 2020. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha K Curley, CRC (310-828-0011 ext. 1007, mahak@footankleinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
injection (time frame: 8 weeks). 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 24 Sep 2020.