Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides (PFESWTCP)

March 5, 2024 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Plantar fascitiis Aged between 18 and 80 years old

Exclusion Criteria:

  • Previous surgery of the foot
  • Contraindications to ESWT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infiltration
1. Infiltration of collagen hydrolyzed peptides
Drug: Collagen hydrolyzed peptides
infiltration near the heal spur of 2ml of Arthrys
Other Names:
  • ESWT
Experimental: ESWT(Extracorporeal Shockwave Therapy)
ESWT (Extracorporeal Shockwave Therapy)
Drug: Collagen hydrolyzed peptides
infiltration near the heal spur of 2ml of Arthrys
Other Names:
  • ESWT
Experimental: Combination
Combination of both treatments
Drug: Collagen hydrolyzed peptides
infiltration near the heal spur of 2ml of Arthrys
Other Names:
  • ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS (Visuoanalogic scale)
Time Frame: Between recruitment and 30 days
Visuoanalogic Scale during walking. Range 0 (No pain) -10 (maximum pain)
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
It is a measurement of active ROM and deambulation of the patient. Range 0 (no function) -100 (perfect function)
Between Recruitment and 15 days
AFAS is American Foot and Ankle Scale
Time Frame: Between Recruitment and 30 days
It is a measurement of active ROM and deambulation of the patient (Range 0-100)
Between Recruitment and 30 days
AFAS is American Foot and Ankle Scale
Time Frame: Between Recruitment and 60 days
It is a measurement of active ROM and deambulation of the patient (Range 0-100)
Between Recruitment and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Investigators

  • Study Chair: Angela Notarnicola, AP, University of Bari
  • Principal Investigator: Silvana DE GIORGI, PI, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFESWTCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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