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

Primary Purpose

Plantar Fasciitis

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Regenseal

normal saline

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring collagen, collagen injection, plantar fasciitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Daejeon Sun HospitalRecruiting
Eulji General HospitalRecruiting
Inje University Seoul Paik HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo injection

Regenseal injection

Arm Description

placebo, normal saline, injection in the plantar facia through randomization

Regenseal, collagen, injection in the plantar facia through randomization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.)

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.)

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.

Full Information

NCT ID

NCT02539082

First Posted

August 31, 2015

Last Updated

September 1, 2015

Sponsor

Sewon Cellontech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02539082

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

April 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sewon Cellontech Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plantar Fasciitis

Keywords

collagen, collagen injection, plantar fasciitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo injection

Arm Type

Placebo Comparator

Arm Description

placebo, normal saline, injection in the plantar facia through randomization

Arm Title

Regenseal injection

Arm Type

Experimental

Arm Description

Regenseal, collagen, injection in the plantar facia through randomization

Intervention Type

Device

Intervention Name(s)

Regenseal

Intervention Description

Regenseal, collagen, injection in the defect area

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

placebo, normal saline, injection in the defect area

Primary Outcome Measure Information:

Title

The difference in the 100mmVAS score

Description

The difference in the 100mmVAS between study group and control group at 3 months after the surgery will be compared and analyzed

Time Frame

3 months after the surgery

Secondary Outcome Measure Information:

Title

The difference in the 100mmVAS score

Description

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.

Time Frame

baseline and 6, 12 months after the surgery

Title

change of the thickness in the sonographic evaluation and fluid collection

Description

Time Frame

baseline and 3, 6, 12 months after the surgery

Title

change of Satisfaction evaluation by physician in charge

Description

Time Frame

baseline and 3, 6, 12 months after the surgery

Title

change of Satisfaction evaluation by patients

Description

Time Frame

baseline and 3, 6, 12 months after the surgery

Title

change score of Degree of recovery

Description

Time Frame

baseline and 3, 6, 12 months after the surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun Jo Kim, Bachelor

Phone

82-2-460-3237

angel@swcell.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Soo Kim, MD

Organizational Affiliation

Eulji General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jae Ho Cho, MD

Organizational Affiliation

Inje University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jun Bum Kim, MD

Organizational Affiliation

Daejeon Sun Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Daejeon Sun Hospital

City

Daejeon

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Bum Kim, MD

Facility Name

Eulji General Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Soo Kim, MD

Facility Name

Inje University Seoul Paik Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jae Ho Cho, MD

12. IPD Sharing Statement

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

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