An interventional study of platelet rich plasma and Normal saline in Fasciitis, Plantar, sponsored by Edna Rath. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Edna Rath · Not applicable, Interventional, and Treatment
A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with Platelet Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with Resistant Plantar Fasciitis
The purpose of this proposal is to perform a high-quality pilot study testing the efficacy of ESWT in combination with PRP for the management of resistant plantar fasciitis. We endeavor to determine if the pilot evidence supports a large, randomized study; and to conduct a power analysis for the follow-on study. The proposed pilot study will be a prospective double-blinded randomized controlled trial comparing pain and functionality at the 3 week, 6 week, 12 week and 6 month marks between extracorporeal shock wave therapy (ESWT) with platelet rich plasma (PRP) injection versus extracorporeal shock wave therapy with placebo injection of normal saline.
267 studies on the registry are indexed under Fasciitis, Plantar; 70 are open to participants now.
Browse Fasciitis, Plantar studies →Edna Rath is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of trauma* or previous injury to heel requiring operative intervention
Any other clinically significant acute or chronic medical conditions (e.g., bleeding disorder) that, in the judgment of the Investigator, would preclude the use of a PRP or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
shockwave therapy within standard of care using Ossatron system with intervention injection of platelet rich plasma (PRP) using Arthex system, into the plantar fascia at the calcaneal origin
Biological: platelet rich plasma
shockwave therapy with placebo normal saline injection
Drug: Normal saline
immediately following shockwave therapy the injection of PRP derived from subjects own blood using Arthex double syringe system will be injected at the origin of the plantar fascia at the calcaneous
Also known as: PRP
placebo injection of normal saline immediately following shockwave therapy
Also known as: Placebo
Visual analog scale (VAS)
Decreased first step pain over time with single treatment of ESWT \& PRP as measured by the VAS
Time frame: 3, 6, 12, 24 weeks
Functional Ankle Ability Measure (FAAM)
functionality scale
Time frame: 3, 6, 12, 24 weeks
Functional Ankle Ability Measure extended sports scale
sports subscale for sport related activity
Time frame: 3, 6, 12, 24 weeks
return to activity
achieving minimal clinical important difference (MCID) on FAAM sport scale
Time frame: 3, 6, 12, 24 weeks
repeat treatment threshold
Decreased need for repeat ESWT as proven by achieving MCID on FAAM
Time frame: 3, 6, 12, 24 weeks
Plan to share: Yes
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Edna Rath