Plantar FasciitisNCT02539082
the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis
A study testing Regenseal and normal saline in people with Plantar Fasciitis, run by Cellontech Co., Ltd. at 3 sites in South Korea.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of collagen injection in patients with plantar fasciitis Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Regenseal and normal saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 24 Jan 2014to 27 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Daejeon Sun Hospital
Daejeon, Daejeon
Eulji General Hospital
Seoul, Seoul
Inje University Seoul Paik Hospital
Seoul, Seoul
About this study
Official title: 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
Read the 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
- Being tested
- Regenseal, normal saline
- Keywords
- collagen, collagen injection, plantar fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegensealDevice
Regenseal, collagen, injection in the defect area
normal salineDrug
placebo, normal saline, injection in the defect area
| Study group | Role | What they receive |
|---|---|---|
| placebo injection | Placebo comparator | placebo, normal saline, injection in the plantar facia through randomization Receives: Drug: normal saline |
| Regenseal injection | Experimental | Regenseal, collagen, injection in the plantar facia through randomization Receives: Device: Regenseal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after the surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.)
Measured: 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.)
Measured: 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.
Measured: baseline and 3, 6, 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start24 Jan 2014
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Soo Kim, MD, Principal investigator, Eulji General HospitalJae Ho Cho, MD, Principal investigator, Inje UniversityJun Bum Kim, MD, Principal investigator, Daejeon Sun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539082
- Sponsor's protocol ID
- 01RGS
- Status last verified
- Nov 2016
- First submitted
- 31 Aug 2015
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Surveillance to Evaluate the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT02539082
- Acronym / sponsor ID
- 01RGS
- Conditions
- Plantar Fasciitis
- Keywords
- collagen, collagen injection, plantar fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo injection | Placebo comparator | Drug: normal salineplacebo, normal saline, injection in the plantar facia through randomization |
| Regenseal injection | Experimental | Device: RegensealRegenseal, collagen, injection in the plantar facia through randomization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegensealRegenseal, collagen, injection in the defect area | Device | Regenseal injection |
| normal salineplacebo, normal saline, injection in the defect area | Drug | placebo injection |
Primary outcome
The difference in the 100mmVAS score
Time frame: 3 months after the surgery
The difference in the 100mmVAS between study group and control group at 3 months after the surgery will be compared and analyzed
5 secondary outcomes
The difference in the 100mmVAS score
Time frame: baseline and 6, 12 months after the surgery
change of the thickness in the sonographic evaluation and fluid collection
Time frame: baseline and 3, 6, 12 months after the surgery
change of Satisfaction evaluation by physician in charge
Time frame: baseline and 3, 6, 12 months after the surgery
change of Satisfaction evaluation by patients
Time frame: baseline and 3, 6, 12 months after the surgery
change score of Degree of recovery
Time frame: baseline and 3, 6, 12 months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Soo Kim, MD principal investigator
Eulji General Hospital
Jae Ho Cho, MD principal investigator
Inje University
Jun Bum Kim, MD principal investigator
Daejeon Sun Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenseal and normal saline in people with Plantar Fasciitis, run by Cellontech Co., Ltd. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the 100mmVAS score (time frame: 3 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.