Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides

NCT ID: NCT06138236

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Plantar Fascitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients suffering from plantar fascitiis were randomized into three arms of treatment: Infiltration of collagen hydrolyzed peptides, ESWT and a combination of both treatments
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Infiltration

1\. Infiltration of collagen hydrolyzed peptides

Group Type EXPERIMENTAL

Collagen hydrolyzed peptides

Intervention Type DRUG

infiltration near the heal spur of 2ml of Arthrys

ESWT(Extracorporeal Shockwave Therapy)

ESWT (Extracorporeal Shockwave Therapy)

Group Type EXPERIMENTAL

Collagen hydrolyzed peptides

Intervention Type DRUG

infiltration near the heal spur of 2ml of Arthrys

Combination

Combination of both treatments

Group Type EXPERIMENTAL

Collagen hydrolyzed peptides

Intervention Type DRUG

infiltration near the heal spur of 2ml of Arthrys

Interventions

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Collagen hydrolyzed peptides

infiltration near the heal spur of 2ml of Arthrys

Intervention Type DRUG

Other Intervention Names

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ESWT

Eligibility Criteria

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Inclusion Criteria

Plantar fascitiis Aged between 18 and 80 years old

Exclusion Criteria

* Previous surgery of the foot
* Contraindications to ESWT
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvana DE GIORGI, PI

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Angela Notarnicola, AP

Role: STUDY_CHAIR

University of Bari

Locations

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Angela Notarnicola

Bari, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Silvana DE GIORGI, PI

Role: CONTACT

3389821930

Facility Contacts

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Angela Notarnicola

Role: primary

0805592938

References

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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.

Reference Type RESULT
PMID: 29504578 (View on PubMed)

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.

Reference Type RESULT
PMID: 30502222 (View on PubMed)

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.

Reference Type RESULT
PMID: 31744313 (View on PubMed)

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.

Reference Type RESULT
PMID: 34038642 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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PFESWTCP

Identifier Type: -

Identifier Source: org_study_id

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