Plantar fasciitis/Achilles tendinitis
Conditions
Interventions
Treatment group:The subjects received injection treatment with PRP prepared with platelet-rich plasma preparation kit produced by Shandong Weigao Xinsheng Medical Instrument Co., LTD
Control group:Subjects received saline (placebo) injection, and after follow-up 12 weeks ±7 days after the last injection) could choose whether to receive PRP prepared with platelet-rich plasma prepar
Sponsors
Shanghai Sixth People's Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years old and = 5 points. b. Clinical diagnosis of Achilles tendinitis, complaint of Achilles tendon pain or limited movement for >= 3 months, and ultrasonography indicated hypoechoic manifestations at the lesion site. 3) Hemoglobin (Hgb) >= 100g/L and platelet count (PLT) >= 100×10^9/L; 4)The subject and/or his/her guardian can understand the purpose of the trial, demonstrate adequate compliance with the trial protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Full skin damage, infection, foot deformity (flat foot, varus foot, tarsal union, etc.); 2) Have a full fracture or a history of foot surgery; 3) The affected foot received local injection therapy in the heel within 6 weeks before or during the screening period; 4) Fasting blood glucose > 8.0mmol/L; 5) Patients with severe heart, liver, lung, kidney failure, severe nervous system disease, severe cardiovascular disease, malignant tumor, sepsis; 6) With severe osteoporosis, bone tuberculosis or malignant tumor; 7) Patients with bleeding diseases (such as hemophilia, vitamin K deficiency, etc.) caused by coagulation factor deficiency or dysfunction, disorders of platelet function (such as giant platelet syndrome, platelet asthenia, storage pool disease, platelet dysfunction syndrome, etc.) or other blood-related diseases that researchers have judged unsuitable for platelet-rich plasma collection; 8) History of systemic glucocorticoid therapy within 2 weeks before or during screening; 9) Received anticoagulation or antiplatelet therapy within 1 week before or during the screening period; 10) Receiving non-steroidal anti-inflammatory drugs within 2 days prior to screening; 11) Body mass index (BMI) greater than 35 kg/m^2; 12) Pregnant and lactating women, or those planning to become pregnant during the study period; 13) Participated in other interventional clinical trials within 1 month before screening; 14) Conditions deemed unsuitable for inclusion by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AOFAS score12 weeks after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analogue pain Scale (VAS);Subject subjective satisfaction score;Product performance evaluation; | — |
Countries
China
Contacts
Public ContactYuan Ting
Shanghai Sixth People's Hospita
Outcome results
None listed