Plantar FascitisEarly Phase 1PFESWTCPNCT06138236
Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides
A Early Phase 1 study testing Collagen hydrolyzed peptides in people with Plantar Fascitis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Collagen hydrolyzed peptides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plantar fascitiis Aged between 18 and 80 years old
Who cannot join
- Previous surgery of the foot
- Contraindications to ESWT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Angela Notarnicola
Bari, 70124
Angela Notarnicola, 0805592938, angelanotarnicola@yahoo.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Plantar Fascitis
- Being tested
- Collagen hydrolyzed peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen hydrolyzed peptidesDrug
Also called ESWT
infiltration near the heal spur of 2ml of Arthrys
| Study group | Role | What they receive |
|---|---|---|
| Infiltration | Experimental | 1. Infiltration of collagen hydrolyzed peptides Receives: Drug: Collagen hydrolyzed peptides |
| ESWT(Extracorporeal Shockwave Therapy) | Experimental | ESWT (Extracorporeal Shockwave Therapy) Receives: Drug: Collagen hydrolyzed peptides |
| Combination | Experimental | Combination of both treatments Receives: Drug: Collagen hydrolyzed peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visuoanalogic scale)
Visuoanalogic Scale during walking. Range 0 (No pain) -10 (maximum pain)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Between Recruitment and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients suffering from plantar fascitiis were randomized into three arms of treatment: Infiltration of collagen hydrolyzed peptides, ESWT and a combination of both treatments
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvana DE GIORGI, PI, Principal investigator, University of BariAngela Notarnicola, AP, Study chair, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138236
- Sponsor's protocol ID
- PFESWTCP
- Acronym
- PFESWTCP
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29504578Sun 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.
PubMed 30502222Xu 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.
PubMed 31744313Melese 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.
PubMed 34038642
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ESWT and Collagen Hydrolyzed Peptides in the Treatment of Plantar Fascitiis
- ClinicalTrials.gov ID
- NCT06138236
- Acronym / sponsor ID
- PFESWTCP / PFESWTCP
- Conditions
- Plantar Fascitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients suffering from plantar fascitiis were randomized into three arms of treatment: Infiltration of collagen hydrolyzed peptides, ESWT and a combination of both treatments
| Arm | Type | Receives |
|---|---|---|
| Infiltration | Experimental | Drug: Collagen hydrolyzed peptides1. Infiltration of collagen hydrolyzed peptides |
| ESWT(Extracorporeal Shockwave Therapy) | Experimental | Drug: Collagen hydrolyzed peptidesESWT (Extracorporeal Shockwave Therapy) |
| Combination | Experimental | Drug: Collagen hydrolyzed peptidesCombination of both treatments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Plantar fascitiis Aged between 18 and 80 years old
Key exclusion criteria (2 listed)
- Previous surgery of the foot
- Contraindications to ESWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen hydrolyzed peptidesAlso: ESWTinfiltration near the heal spur of 2ml of Arthrys | Drug | Combination, ESWT(Extracorporeal Shockwave Therapy), Infiltration |
Primary outcome
VAS (Visuoanalogic scale)
Time frame: Between recruitment and 30 days
Visuoanalogic Scale during walking. Range 0 (No pain) -10 (maximum pain)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Results publication: PubMed 29504578Lai 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.
- Results publication: PubMed 30502222Sun 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.
- Results publication: PubMed 31744313Xu 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.
- Results publication: PubMed 34038642Melese 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvana DE GIORGI, PI principal investigator
University of Bari
Angela Notarnicola, AP study chair
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Collagen hydrolyzed peptides in people with Plantar Fascitis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. 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 Italy. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvana DE GIORGI, PI (3389821930, silvana.degiorgi@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visuoanalogic scale) (time frame: Between recruitment and 30 days). The study lists 4 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 NCT06138236, which also lists 4 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 8 Dec 2025.