The primary objective of this study is to evaluate the safety and efficacy of collagen injection in patients with plantar fasciitis
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
60
Regenseal, collagen, injection in the defect area
placebo, normal saline, injection in the defect area
Daejeon Sun Hospital
Daejeon, Daejeon, South Korea
Eulji General Hospital
Seoul, Seoul, South Korea
Inje University Seoul Paik Hospital
Seoul, Seoul, South Korea
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
Time frame: 3 months after the surgery
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.
Time frame: 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.
Time frame: 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.)
Time frame: 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.)
Time frame: baseline and 3, 6, 12 months after the surgery
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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.
Time frame: baseline and 3, 6, 12 months after the surgery