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Plantar FascitisPhase 3PF:AutovsPRPNCT05240872

Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis

A Phase 3 study testing PRP injection and ABI injection in people with Plantar Fascitis, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Plantar Fascitis
What is being tested?
PRP injection and ABI injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2020to 15 Jan 2022
Phase
Phase 3
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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who were diagnosed with chronic plantar fasciitis
  • Nonresponded to o conservative treatment (stretching exercises, nonsteroidal anti-inflammatory drugs, and heel pads) for at least 6 weeks
  • Patient should be able to understand the informed consent about type of treatment and blindness and randomization
  • Visual analog scale pain higher than 5 (on a 10-point visual analog scale)

Who cannot join

  • previous history of any type of local injection treatment for heel pain
  • history of surgery for heel pain, foot and ankle disorders, fractures
  • Associated pathology involving the lower limb such as
  • tarsal tunnel syndrome
  • effusion of the ankle indicating an intra-articular disease
  • Peroneal/Achilles/tibialis tendons pathology
Show all 10Show fewer
  • any obvious deformity of foot and ankle,
  • Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout
  • Pregnancy
  • Use of antiocoagulation -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Atasehir Florence Nightingale Hospital

    Ataşehir, Istanbul, 34750

Other trials in Turkey (Türkiye)

About this study

Official title: Is There Any Advantage of PRP Over Autologous Blood Injection in the Treatment of Chronic Plantar Fasciitis? A Prospective Randomized Double Blinded Study

To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis

Read the detailed description

After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to web based block group randomization. Patients were evaluated prior to injection in terms of Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated measure ANOVA test used for statistical analysis

Being tested
PRP injection, ABI injection
Keywords
heel pain, platelet rich plasm, autologous blood injection

What participants receive

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

  • PRP injectionBiological

    Plantar fascia injection therapy with PRP

  • ABI injectionBiological

    ABI injection

Study groups in NCT05240872
Study groupRoleWhat they receive
Group AActive comparatorPlatelet Rich Plasm (PRP) injection group
Receives: Biological: PRP injection
Group BActive comparatorAutologous Blood injection (ABI) group
Receives: Biological: ABI injection

What is being measured

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

  1. Changes in Visual Analogue Scale (VAS)

    Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome

    Measured: 0,1 st 3rd and 6th month; changes between time points will be assessed

  2. Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score

    American Orthopaedic Foot \& Ankle Society (AOFAS) Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes Evaluation:0 worst 100 best

    Measured: 0,1 st 3rd and 6th month; changes between time points will be assessed

  3. Changes in Foot and Ankle Disability Index (FADI)

    Foot and Ankle Disability Index Evaluation:0 worst 100 best

    Measured: 0,1 st 3rd and 6th month; changes between time points will be assessed

Timeline

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

  1. First posted15 Feb 2022
  2. Study start1 Mar 2020
  3. Primary completion30 Oct 2020
  4. Study completion15 Jan 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240872
Sponsor's protocol ID
13.02.2020/008
Acronym
PF:AutovsPRP
Status last verified
Feb 2022
First submitted
13 Feb 2022
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to permission of Institutional Review of Board and Ethical Committee; Participating demographics, outcome measures may be shared

Publications

  • Kalia RB, Singh V, Chowdhury N, Jain A, Singh SK, Das L. Role of Platelet Rich Plasma in Chronic Plantar Fasciitis: A Prospective Study. Indian J Orthop. 2020 Oct 6;55(Suppl 1):142-148. doi: 10.1007/s43465-020-00261-w. eCollection 2021 May.

    PubMed 34122767

  • Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan.

    PubMed 35097359

  • Bagcier F, Yilmaz N. The Impact of Extracorporeal Shock Wave Therapy and Dry Needling Combination on Pain and Functionality in the Patients Diagnosed with Plantar Fasciitis. J Foot Ankle Surg. 2020 Jul-Aug;59(4):689-693. doi: 10.1053/j.jfas.2019.09.038. Epub 2020 Apr 25.

    PubMed 32340838

  • Landorf KB. Plantar heel pain and plantar fasciitis. BMJ Clin Evid. 2015 Nov 25;2015:1111.

    PubMed 26609884

  • Stuber K, Kristmanson K. Conservative therapy for plantar fasciitis: a narrative review of randomized controlled trials. J Can Chiropr Assoc. 2006 Jun;50(2):118-33.

    PubMed 17549177

  • Martin JE, Hosch JC, Goforth WP, Murff RT, Lynch DM, Odom RD. Mechanical treatment of plantar fasciitis. A prospective study. J Am Podiatr Med Assoc. 2001 Feb;91(2):55-62. doi: 10.7547/87507315-91-2-55.

    PubMed 11266478

  • Kaya O, Hurel C, Gumussuyu G, Kose O. Bilateral calcaneal insufficiency fractures due to chronic carbamazepine use for trigeminal neuralgia: A case report. Niger J Clin Pract. 2020 Apr;23(4):574-576. doi: 10.4103/njcp.njcp_515_18.

    PubMed 32246668

  • Gupta R, Malhotra A, Masih GD, Khanna T, Kaur H, Gupta P, Kashyap S. Comparing the Role of Different Treatment Modalities for Plantar Fasciitis: A Double Blind Randomized Controlled Trial. Indian J Orthop. 2020 Jan 20;54(1):31-37. doi: 10.1007/s43465-019-00038-w. eCollection 2020 Feb.

    PubMed 32257015

  • Mahindra P, Yamin M, Selhi HS, Singla S, Soni A. Chronic Plantar Fasciitis: Effect of Platelet-Rich Plasma, Corticosteroid, and Placebo. Orthopedics. 2016 Mar-Apr;39(2):e285-9. doi: 10.3928/01477447-20160222-01. Epub 2016 Feb 25.

    PubMed 26913766

  • Singh P, Madanipour S, Bhamra JS, Gill I. A systematic review and meta-analysis of platelet-rich plasma versus corticosteroid injections for plantar fasciopathy. Int Orthop. 2017 Jun;41(6):1169-1181. doi: 10.1007/s00264-017-3470-x. Epub 2017 Apr 10.

    PubMed 28396927

  • Jain SK, Suprashant K, Kumar S, Yadav A, Kearns SR. Comparison of Plantar Fasciitis Injected With Platelet-Rich Plasma vs Corticosteroids. Foot Ankle Int. 2018 Jul;39(7):780-786. doi: 10.1177/1071100718762406. Epub 2018 Mar 30.

    PubMed 29600719

  • Yu T, Xia J, Li B, Zhou H, Yang Y, Yu G. Outcomes of platelet-rich plasma for plantar fasciopathy: a best-evidence synthesis. J Orthop Surg Res. 2020 Sep 21;15(1):432. doi: 10.1186/s13018-020-01783-7.

    PubMed 32958046

  • Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouche R, Baker J; American College of Foot and Ankle Surgeons heel pain committee. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010 May-Jun;49(3 Suppl):S1-19. doi: 10.1053/j.jfas.2010.01.001.

    PubMed 20439021

  • Shetty SH, Dhond A, Arora M, Deore S. Platelet-Rich Plasma Has Better Long-Term Results Than Corticosteroids or Placebo for Chronic Plantar Fasciitis: Randomized Control Trial. J Foot Ankle Surg. 2019 Jan;58(1):42-46. doi: 10.1053/j.jfas.2018.07.006. Epub 2018 Nov 15.

    PubMed 30448183

  • Crawford F, Atkins D, Young P, Edwards J. Steroid injection for heel pain: evidence of short-term effectiveness. A randomized controlled trial. Rheumatology (Oxford). 1999 Oct;38(10):974-7. doi: 10.1093/rheumatology/38.10.974.

    PubMed 10534548

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRP injection and ABI injection in people with Plantar Fascitis, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).

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 4 inclusion and 10 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: finished, as of the sponsor's last update on 2 Mar 2022. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in Visual Analogue Scale (VAS) (time frame: 0,1 st 3rd and 6th month; changes between time points will be assessed). The study lists 3 primary outcomes in all. 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 NCT05240872, which also lists 26 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 2 Mar 2022.

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