NCT06138236

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

July 21, 2023

Last Update Submit

December 2, 2025

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (4)

  • VAS (Visuoanalogic scale)

    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

    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

    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

    It is a measurement of active ROM and deambulation of the patient (Range 0-100)

    Between Recruitment and 60 days

Study Arms (3)

Infiltration

EXPERIMENTAL

1\. Infiltration of collagen hydrolyzed peptides

Drug: Collagen hydrolyzed peptides

ESWT(Extracorporeal Shockwave Therapy)

EXPERIMENTAL

ESWT (Extracorporeal Shockwave Therapy)

Drug: Collagen hydrolyzed peptides

Combination

EXPERIMENTAL

Combination of both treatments

Drug: Collagen hydrolyzed peptides

Interventions

Collagen hydrolyzed peptidesDRUG

infiltration near the heal spur of 2ml of Arthrys

Also known as: ESWT
CombinationESWT(Extracorporeal Shockwave Therapy)Infiltration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Plantar fascitiis Aged between 18 and 80 years old

You may not qualify if:

  • Previous surgery of the foot
  • Contraindications to ESWT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angela Notarnicola

Bari, 70124, Italy

RECRUITING

Related Publications (4)

  • 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: 29504578RESULT

  • 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: 30502222RESULT

  • 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: 31744313RESULT

  • 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: 34038642RESULT

Study Officials

  • Silvana DE GIORGI, PI

    University of Bari

    PRINCIPAL INVESTIGATOR

  • Angela Notarnicola, AP

    University of Bari

    STUDY CHAIR

Central Study Contacts

Silvana DE GIORGI, PI

CONTACT

3389821930silvana.degiorgi@uniba.it

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients suffering from plantar fascitiis were randomized into three arms of treatment: Infiltration of collagen hydrolyzed peptides, ESWT and a combination of both treatments
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2023

First Posted

November 18, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations

IT(1)