Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides

Early Phase 1

Recruiting

• Conditions: Plantar Fascitis
• Interventions: Drug: Collagen hydrolyzed peptides

• Registration Number: NCT06138236
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

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 Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Plantar fascitiis Aged between 18 and 80 years old

Exclusion Criteria

• Previous surgery of the foot
• Contraindications to ESWT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT(Extracorporeal Shockwave Therapy)	Collagen hydrolyzed peptides	ESWT (Extracorporeal Shockwave Therapy)
Infiltration	Collagen hydrolyzed peptides	1. Infiltration of collagen hydrolyzed peptides
Combination	Collagen hydrolyzed peptides	Combination of both treatments

Primary Outcome Measures

Name	Time	Method
VAS (Visuoanalogic scale)	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	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	Between Recruitment and 60 days	It is a measurement of active ROM and deambulation of the patient (Range 0-100)

Trial Locations

Locations (1)

Angela Notarnicola; 🇮🇹 Bari, Italy