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

NCT02539082 | Unknown Phase 4 DMC

• 1 other identifier: 01RGS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Plantar Fasciitis

Keywords

collagen; collagen injection; plantar fasciitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The difference in the 100mmVAS score

  baseline and 6, 12 months after the surgery

• change of the thickness in the sonographic evaluation and fluid collection

  baseline and 3, 6, 12 months after the surgery

• change of Satisfaction evaluation by physician in charge

  baseline and 3, 6, 12 months after the surgery

• change of Satisfaction evaluation by patients

  baseline and 3, 6, 12 months after the surgery

• change score of Degree of recovery

  baseline and 3, 6, 12 months after the surgery

Study Arms (2)

placebo injection

PLACEBO COMPARATOR

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

Drug: normal saline

Regenseal injection

EXPERIMENTAL

Regenseal, collagen, injection in the plantar facia through randomization

Device: Regenseal

Interventions

Regenseal DEVICE

Regenseal, collagen, injection in the defect area

Regenseal injection

normal saline DRUG

placebo, normal saline, injection in the defect area

placebo injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \. 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

You may not qualify if:

• \. If patients or their families suffer from or have ever suffered from an autoimmune disease.
• \. 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.

Sponsors & Collaborators

• Sewon Cellontech Co., Ltd.: lead

Study Sites (3)

Daejeon Sun Hospital

Daejeon, Daejeon, South Korea

RECRUITING

Eulji General Hospital

Seoul, Seoul, South Korea

RECRUITING

Inje University Seoul Paik Hospital

Seoul, Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jin Soo Kim, MD

  Eulji General Hospital

  PRINCIPAL INVESTIGATOR

• Jae Ho Cho, MD

  Inje University

  PRINCIPAL INVESTIGATOR

• Jun Bum Kim, MD

  Daejeon Sun Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Jo Kim, Bachelor

CONTACT

82-2-460-3237; angel@swcell.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: November 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

KR (3)