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Recruiting NCT06138236

Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides

Early Phase I Interventional Plantar Fascitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collagen hydrolyzed peptides.
Who it may be relevant to
Registry conditions: Plantar Fascitis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of ESWT and Collagen Hydrolyzed Peptides in the Treatment of Plantar Fascitiis

Overview

Patients suffering from Plantar Fasciitis were randomized into three groups: the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

Detailed description

Patients suffering from Plantar Fasciitis were randomized into three groups:

the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

Aim of the study was to consider any difference in the outcome of the three groups of patients. The NRS and the AFAS score were considered for the outcome measurement.

Interventions

  • Drug Collagen hydrolyzed peptides
    infiltration near the heal spur of 2ml of Arthrys

Primary outcome measures

  • VAS (Visuoanalogic scale) [Time frame: Between recruitment and 30 days]
  • AFAS (American Foot and Ankle Score) is the American Foot and Ankle Scale [Time frame: Between Recruitment and 15 days]
  • AFAS is American Foot and Ankle Scale [Time frame: Between Recruitment and 30 days]
  • AFAS is American Foot and Ankle Scale [Time frame: Between Recruitment and 60 days]

Eligibility criteria

Inclusion criteria

Plantar fascitiis Aged between 18 and 80 years old

Exclusion criteria

  • Previous surgery of the foot
  • Contraindications to ESWT

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Angela Notarnicola — Bari

Publications

  • Lai TW, Ma HL, Lee MS, Chen PM, Ku MC. Ultrasonography and clinical outcome comparison of extracorporeal shock wave therapy and corticosteroid injections for chronic plantar fasciitis: A randomized controlled trial. J Musculoskelet Neuronal Interact. 2018 Mar 1;18(1):47-54. PMID 29504578
  • Sun K, Zhou H, Jiang W. Extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis. Foot Ankle Surg. 2020 Jan;26(1):33-38. doi: 10.1016/j.fas.2018.11.002. Epub 2018 Nov 13. PMID 30502222
  • Xu D, Jiang W, Huang D, Hu X, Wang Y, Li H, Zhou S, Gan K, Ma W. Comparison Between Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection for Plantar Fasciitis. Foot Ankle Int. 2020 Feb;41(2):200-205. doi: 10.1177/1071100719891111. Epub 2019 Nov 19. PMID 31744313
  • Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26. PMID 34038642

Identifiers

NCT: NCT06138236 · PFESWTCP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗