Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides

Plantar Fascitis Clinical Trial

— PFESWTCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138236
• Other study ID #: PFESWTCP
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: Silvana DE GIORGI, PI
• Phone: 3389821930
• Email: silvana.degiorgi[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Plantar fascitiis Aged between 18 and 80 years old

Exclusion Criteria:

• Previous surgery of the foot
• Contraindications to ESWT

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

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

Locations

Country	Name	City	State
Italy	Angela Notarnicola	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Country where clinical trial is conducted

Italy, 

References & 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 — View Citation

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. do — View Citation

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. — View Citation

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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS (Visuoanalogic scale)	Visuoanalogic Scale during walking. Range 0 (No pain) -10 (maximum pain)	Between recruitment and 30 days
Primary	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
Primary	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
Primary	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