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

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

Study Overview

• Status: Unknown
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Drug: normal saline; Device: Regenseal

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.)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hyun Jo Kim, Bachelor; Phone Number: 82-2-460-3237; Email: angel@swcell.com

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Recruiting
    • Daejeon Sun hospital
    • Principal Investigator: Jun Bum Kim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Eulji General Hospital
    • Principal Investigator: Jin Soo Kim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Inje University Seoul Paik Hospital
    • Principal Investigator: Jae Ho Cho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo injection; placebo, normal saline, injection in the plantar facia through randomization	Drug: normal saline; placebo, normal saline, injection in the defect area
Experimental: Regenseal injection; Regenseal, collagen, injection in the plantar facia through randomization	Device: Regenseal; Regenseal, collagen, injection in the defect area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sewon Cellontech Co., Ltd.
• Investigators: Principal Investigator: Jin Soo Kim, MD, Eulji General Hospital; Principal Investigator: Jae Ho Cho, MD, Inje University; Principal Investigator: Jun Bum Kim, MD, Daejeon Sun hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: collagen; plantar fasciitis; collagen injection
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 01RGS