NCT02539082

the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis

A Post-marketing Surveillance to Evaluate the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of collagen injection in patients with plantar fasciitis

Detailed description

This study is an open-trial study. Sixty subjects will be participated in it. The study will be explained to the subjects and they voluntarily agreed to participate in it. Their eligibility to participate in the study will be checked, and the patient will receive collagen or a placebo (normal saline) in the plantar facia through randomization. They will be asked to follow the guidelines of the investigators during the study and to visit the hospital seven times, including for screening and the date of re-injection. . At each visit, the subjects undergo a VAS, a clinical laboratory tests, and a physical exam to evaluate the safety and efficacy of Regenseal. (\*Re-injection could be maximum 2times at visit2 and 3, one week apart based on the investigator's judgment after the initial injection. If the subject gets injection on the screening date, the total number of his or her visits will be six.)

Conditions

• Plantar Fasciitis

Interventions

Type	Name	Description
DEVICE	Regenseal	Regenseal, collagen, injection in the defect area
DRUG	normal saline	placebo, normal saline, injection in the defect area

Timeline

• Start date: 2014-01-24
• Primary completion: 2018-12-27
• Completion: 2018-12-27
• First posted: 2015-09-02
• Last updated: 2026-04-07

Locations

3 sites across 1 country: South Korea