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

Last updated: September 1, 2015
Sponsor: Sewon Cellontech Co., Ltd.
Overall Status: Trial Status Unknown

Phase

4

Condition

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT02539082
01RGS
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Patient with chronic plantar fasciitis (Patients who had been diagnosed with plantarfasciitis 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 ofthe study drug and who read and understood the guidelines 3. Patients who agreed tomaintain 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 whoagreed not to use physical therapy or shock wave during the study period.
  1. 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

Exclusion Criteria:

    1. If patients or their families suffer from or have ever suffered from an autoimmunedisease.
  1. Patients who have ever suffered an anaphylactic reaction. 3. Patients who have eversuffered hypersensitivity to an implant. 4. Patients with a history of allergy toporcine or bovine protein. 5. Patients with rheumatoid arthritis. 6. Patients withankylosing spondylitis. 7. Patients who are suspected of having spinal deformity witha negative serum test 8. Subjects who are pregnant and/or breast-feeding and/or plan apregnancy. 9. Subjects with psychiatric disorders who are considered inappropriate toparticipate in this trial by the Principal Investigator.

Study Design

Total Participants: 60
Study Start date:
November 01, 2013
Estimated Completion Date:
December 31, 2016

Study 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.)

Connect with a study center

  • Daejeon Sun Hospital

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Eulji General Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Inje University Seoul Paik Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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