AzTrials
AzTrials

Fasciitis, PlantarNCT02668510

RCT Comparing ESWT With PRP for Plantar Fasciitis in High Demand Cohort

A study testing platelet rich plasma and Normal saline in people with Fasciitis, Plantar, run by Edna Rath at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Fasciitis, Plantar
What is being tested?
platelet rich plasma and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2016to 11 Dec 2023
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Patients that are already selected for ESWT for the treatment of resistant plantar fasciitis as part of clinical care under the doctor-patient relationship
  • X-ray imaging studies (Plain radiographs) documenting no additional sources for heel pain within 12 months(all x-rays were conducted as part of standard of care and no radiation will be specific to the research study)
  • Active Duty Soldier as they are a high demand cohort with increased frequency of plantar fasciitis compared to the general population as outlined by Scher et al.
  • Previously tried conservative management meeting referral to Orthopaedics: Pain medications, taping, orthoses, night splinting or physical therapy
  • Body Mass Index (BMI) <40kg/m2

Who cannot join

  • • History of trauma* or previous injury to heel requiring operative intervention
  • All Soldiers pending medical board evaluation or punitive action
  • History of connective tissue disorder (e.g., Marfan's Syndrome, Ehlers-Danlos disease, Rheumatoid Arthritis, etc.)
  • Leaving the geographical area permanently or for extended periods of time forcing loss to follow up
  • Treatment for plantar fasciitis with injection within the last 6 months
  • Surgical indication or internal derangement of the foot
Show all 16Show fewer
  • Chronic pain conditions
  • Pregnancy
  • Tarsal tunnel syndrome
  • Baxter's neuritis
  • Rigid flat foot
  • Active infection of the Foot overlying the injection area
  • Use of immunomodulators, immunosuppressives, or chemotherapeutic agents
  • Allergy or hypersensitivity to any of the proposed treatment medications
  • 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.
  • Trauma for this research study is defined as a specific event or mechanism of injury, such as a direct blow or twisting injury of the foot that initiated the onset of heel pain. The insidious onset of heel pain with prolonged running or other physical activity is not defined as a traumatic event.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • William Beaumont Army Medical Center

    El Paso, Texas, 79920

Other trials in United States

About this study

Official title: 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

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

Read the detailed description

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.

Being tested
platelet rich plasma, Normal saline
Keywords
Heel Pain, extracorporeal shock wave therapy, ESWT, shock wave, Soldiers, Platelet rich plasma, PRP, Autologous conditioned plasma, Military
Medical subject headings
Fasciitis, Plantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • platelet rich plasmaBiological

    Also called PRP

    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

  • Normal salineDrug

    Also called Placebo

    placebo injection of normal saline immediately following shockwave therapy

Study groups in NCT02668510
Study groupRoleWhat they receive
Platelet Rich Plasma Injection GroupExperimentalshockwave 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
Receives: Biological: platelet rich plasma
Placebo injection groupPlacebo comparatorshockwave therapy with placebo normal saline injection
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analog scale (VAS)

    Decreased first step pain over time with single treatment of ESWT \& PRP as measured by the VAS

    Measured: 3, 6, 12, 24 weeks

Secondary outcomes (4)

  1. Functional Ankle Ability Measure (FAAM)

    functionality scale

    Measured: 3, 6, 12, 24 weeks

  2. Functional Ankle Ability Measure extended sports scale

    sports subscale for sport related activity

    Measured: 3, 6, 12, 24 weeks

  3. return to activity

    achieving minimal clinical important difference (MCID) on FAAM sport scale

    Measured: 3, 6, 12, 24 weeks

  4. repeat treatment threshold

    Decreased need for repeat ESWT as proven by achieving MCID on FAAM

    Measured: 3, 6, 12, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completion11 Dec 2023
  4. Study completion11 Dec 2023

Why it stopped: Withdrawn as researcher left before data collection could be completed

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02668510
Sponsor's protocol ID
16/03
Status last verified
Sep 2025
First submitted
26 Jan 2016
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Ogden JA, Cross GL, Williams SS. Bilateral chronic proximal plantar fasciopathy: treatment with electrohydraulic orthotripsy. Foot Ankle Int. 2004 May;25(5):298-302. doi: 10.1177/107110070402500504.

    PubMed 15134609

  • Chew KT, Leong D, Lin CY, Lim KK, Tan B. Comparison of autologous conditioned plasma injection, extracorporeal shockwave therapy, and conventional treatment for plantar fasciitis: a randomized trial. PM R. 2013 Dec;5(12):1035-43. doi: 10.1016/j.pmrj.2013.08.590. Epub 2013 Aug 22.

    PubMed 23973504

  • Aqil A, Siddiqui MR, Solan M, Redfern DJ, Gulati V, Cobb JP. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: a meta-analysis of RCTs. Clin Orthop Relat Res. 2013 Nov;471(11):3645-52. doi: 10.1007/s11999-013-3132-2. Epub 2013 Jun 28.

    PubMed 23813184

  • Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.

    PubMed 16309613

  • Metzner G, Dohnalek C, Aigner E. High-energy Extracorporeal Shock-Wave Therapy (ESWT) for the treatment of chronic plantar fasciitis. Foot Ankle Int. 2010 Sep;31(9):790-6. doi: 10.3113/FAI.2010.0790.

    PubMed 20880482

  • Yin MC, Ye J, Yao M, Cui XJ, Xia Y, Shen QX, Tong ZY, Wu XQ, Ma JM, Mo W. Is extracorporeal shock wave therapy clinical efficacy for relief of chronic, recalcitrant plantar fasciitis? A systematic review and meta-analysis of randomized placebo or active-treatment controlled trials. Arch Phys Med Rehabil. 2014 Aug;95(8):1585-93. doi: 10.1016/j.apmr.2014.01.033. Epub 2014 Mar 21.

    PubMed 24662810

  • de Mos M, van der Windt AE, Jahr H, van Schie HT, Weinans H, Verhaar JA, van Osch GJ. Can platelet-rich plasma enhance tendon repair? A cell culture study. Am J Sports Med. 2008 Jun;36(6):1171-8. doi: 10.1177/0363546508314430. Epub 2008 Mar 7.

    PubMed 18326832

  • O'Malley MJ, Vosseller JT, Gu Y. Successful use of platelet-rich plasma for chronic plantar fasciitis. HSS J. 2013 Jul;9(2):129-33. doi: 10.1007/s11420-012-9321-9. Epub 2013 May 18.

    PubMed 24426857

  • Ang TW. The effectiveness of corticosteroid injection in the treatment of plantar fasciitis. Singapore Med J. 2015 Aug;56(8):423-32. doi: 10.11622/smedj.2015118.

    PubMed 26311907

  • Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257.

    PubMed 19952249

Questions about this trial

What is this clinical trial studying?

A study testing platelet rich plasma and Normal saline in people with Fasciitis, Plantar, run by Edna Rath 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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 25 Sep 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analog scale (VAS) (time frame: 3, 6, 12, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02668510, which also lists 10 linked publications.

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 25 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in