NCT02196155 Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis
| NCT ID | NCT02196155 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Plantar Fasciitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2016-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2016-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics. Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best. The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT). However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed.
Eligibility Criteria
Inclusion Criteria: * Clinical symptoms of a plantar fasciitis * Plantar fasciitis in MRI * Exclusion of differential diagnoses * Symptoms more than 3 months * Absolution of 3 months unsuccessful treatment * Written informed consent Exclusion Criteria * Active differential diagnoses * Contraindications: pregnancy and breastfeeding, infection at injection sites, allergy against BTX-A * Previous injections or surgery for plantar fasciitis * Neurological diseases affecting the peripheral nervous system
Contact & Investigator
Fabian Krause, PD Dr.
PRINCIPAL INVESTIGATOR
Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland
Frequently Asked Questions
Who can join the NCT02196155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Plantar Fasciitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02196155 currently recruiting?
Yes, NCT02196155 is actively recruiting participants. Contact the research team at fabian.krause@insel.ch for enrollment information.
Where is the NCT02196155 trial being conducted?
This trial is being conducted at Bern, Switzerland, Lucerne, Switzerland.
Who is sponsoring the NCT02196155 clinical trial?
NCT02196155 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Fabian Krause, PD Dr. at Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland. The trial plans to enroll 54 participants.