Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equ… (NCT03978234) | Clinical Trial Compass
UnknownPhase 2
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
United States30 participantsStarted 2019-11-20
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.