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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides

NCT06138236

Plantar Fascitis

RECRUITING EARLY_PHASE1

Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.

NCT05389059

Gingival Diseases Traumatic Injury

UNKNOWN NA

Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession

NCT03199118

Gingival Recession

COMPLETED NA

Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing

NCT05821725

Palatal Wound

COMPLETED NA

Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix

NCT04462237

Gingival Recession Platelet Derived Growth Factor

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Plantar Fasciitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo injection

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

placebo, normal saline, injection in the defect area

Regenseal injection

Regenseal, collagen, injection in the plantar facia through randomization

Group Type EXPERIMENTAL

Regenseal

Intervention Type DEVICE

Regenseal, collagen, injection in the defect area

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Regenseal

Regenseal, collagen, injection in the defect area

Intervention Type DEVICE

normal saline

placebo, normal saline, injection in the defect area

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes