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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02539082
• Other study ID #: 01RGS
• Status: Recruiting
• Phase: Phase 4
• First received: August 31, 2015
• Last updated: September 1, 2015
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Sewon Cellontech Co., Ltd.
• Contact: Hyun Jo Kim, Bachelor
• Phone: 82-2-460-3237
• Email: angel[@]swcell.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1. Patient with chronic plantar fasciitis (Patients who had been diagnosed with plantar fasciitis but had not been responsive to non-invasive treatment for more than three months (non-invasive treatments include drugs, physiotherapy shock wave, or stretching) 2. Patients who are able to complete the questionnaires related to the safety and efficacy of the study drug and who read and understood the guidelines 3. Patients who agreed to maintain the medication dose during the study period if they need to keep taking it. (Excluded anti-inflammatory analgesic drug for pain after the injection.) 4. Patients who agreed not to use physical therapy or shock wave during the study period.

5. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

• 1. If patients or their families suffer from or have ever suffered from an autoimmune disease.

2. Patients who have ever suffered an anaphylactic reaction. 3. Patients who have ever suffered hypersensitivity to an implant. 4. Patients with a history of allergy to porcine or bovine protein. 5. Patients with rheumatoid arthritis. 6. Patients with ankylosing spondylitis. 7. Patients who are suspected of having spinal deformity with a negative serum test 8. Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy. 9. Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• Regenseal
Regenseal, collagen, injection in the defect area

Drug:
• normal saline
placebo, normal saline, injection in the defect area

Locations

Country	Name	City	State
Korea, Republic of	Daejeon Sun Hospital	Daejeon
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sewon Cellontech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the 100mmVAS score	The difference in the 100mmVAS between study group and control group at 3 months after the surgery will be compared and analyzed	3 months after the surgery	No
Secondary	The difference in the 100mmVAS score	The difference in the 100mmVAS between study group and control group at baseline and 6, 12 months after the surgery will be compared and analyzed.	baseline and 6, 12 months after the surgery	No
Secondary	change of the thickness in the sonographic evaluation and fluid collection	The difference between study group and control group of the thickness in the sonographic evaluation and fluid collection at baseline will be compared with that three months after the surgery. The thickness in the sonographic evaluation and fluid collection six and 12 months will be additionally taken for comparison and analysis.	baseline and 3, 6, 12 months after the surgery	No
Secondary	change of Satisfaction evaluation by physician in charge	The improvements on the affected ankle by physician in charge at 3 months after injection and six, 12months after injection of the study and control group will be compared and analyzed. (Physician in charge evaluates the degree of improvement in 5 levels, such as 'excellent, good, satisfactory, no change, and worsened.)	baseline and 3, 6, 12 months after the surgery	No
Secondary	change of Satisfaction evaluation by patients	The improvements on the affected ankle at 3 months after injection and six, 12 months after injection of the study and control group will be compared and analyzed. (Patient evaluates the degree of improvement in 5 levels, such as 'excellent, good, satisfactory, no change, and worsened.)	baseline and 3, 6, 12 months after the surgery	No
Secondary	change score of Degree of recovery	The score of degree of recovery at baseline will be recorded. The difference between study group and control group in the score of degree of recovery at three, six, and 12months after injection will be compared and analyzed.	baseline and 3, 6, 12 months after the surgery	No