Results of the injection of botulinum toxin vs platelet rich plasma for the treatment of plantar fasciitis

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000575-32-ES

Enrollment

Registered

2018-11-23

Start date

2018-12-18

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar fasciitis MedDRA version: 20.0 Level: PT Classification code 10035155 Term: Plantar fasciitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: BOTOX Product Name: BOTOX Pharmaceutical Form: Powder for solution for injection/infusion Product Name: platelet rich plasma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Clinic diagnosis of plantar fasciitis - Failure of conservative treatment for 3 months - Informed consent understood and signed - Patients aged 18 or more - No previous injections or surgery to treat plantar fasciitis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 51 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Inflammatory arthropathies (Rheumatoid arthritis, psoriasis, Reiter’s síndrome, ankylosing spondylitis) - Neurologic diseases - Mental retardation or psychiatric abnormalities which can lead misunderstanding of the informed consent - Cutaneous infection - History of infection in the previous 3 months at the application site - Patients who do not complete the follow-up appointments - Previous treatements for plantar fasciitis including injections, surgery or extracorporeal shock wave - Syntomps during less than 3 months - Surgery in the lower limb within the last 6 months - Pregancy and lactancy - Oral anticoagulants

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effectiveness of botulinum toxin type A vs platelet rich plasma injections to treat plantar fasciitis, and with a control group without injections.; Secondary Objective: To evaluate changes in fascia plantar thickness by ultrasonography. To do an analysis cost-effectiveness ; Primary end point(s): • Pain (VAS) • Function (AOFAS, ROM, Silverskiold test) • Quality of life (SF-36) ; Timepoint(s) of evaluation of this end point: • 1st visit • 3 weeks • 3 months • 6 months • 1 year	—

Measure

Time frame

Main Objective: To compare the effectiveness of botulinum toxin type A vs platelet rich plasma injections to treat plantar fasciitis, and with a control group without injections.; Secondary Objective: To evaluate changes in fascia plantar thickness by ultrasonography. To do an analysis cost-effectiveness ; Primary end point(s): • Pain (VAS) • Function (AOFAS, ROM, Silverskiold test) • Quality of life (SF-36) ; Timepoint(s) of evaluation of this end point: • 1st visit • 3 weeks • 3 months • 6 months • 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): • Inflammation (Plantar fascia thickness measured by US) - Cost-effectiveness analysis of both treatments and versus no intervention ; Timepoint(s) of evaluation of this end point: • 1st visit • 3 weeks • 3 months • 6 months • 1 year	—

Countries

Spain

Contacts

Public ContactSecretaría Traumatología

Hospital Son Llátzer

xavigas@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026