Clinical efficacy and safety of CollaDerm in the management of diabetic foot ulcers

Yonsei University Health System, Severance Hospital0 个研究点目标入组 38 人开始时间: 待定最近更新: 2019年4月23日

试验速览

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•1) patients with type 1 or type 2 diabetes over 20 years of age
•2) Wagner classification of grade 1 and 2 patients with lower limb ulcer
•3) Ulcer size = 1 ?
•4) Patients who had diabetic foot ulcer for more than 6 weeks
•5) If there is any of the following three conditions in the leg with a target foot ulcer at the previous treatment day (V1)
•? One or more of the foot arterial sounds of the ankle joint region through Doppler examination
•? Percutaneous oxygen partial pressure greater than 30 mmHg
•? When pulse is palpable
•6) Patients who were negative for microbiological culture after appropriate antibiotic treatment even without systemic or local infection or with infection
•7) Subjects who have received sufficient explanations for this clinical trial and then signed the agreement

•1) Pregnant or lactating women and women of childbearing age who refuse a contraception during the study
•2) Patients with sepsis, osteomyelitis, abscess, gangrene or soft tissue infection treated unsuccessfully with debridement
•3) Patients diagnosed as venous insufficiency, diabetic fatty necrosis and ulcer with deep vein thrombosis
•4) Patients had connective tissue disorder that interferes with wound healing, such as rheumatoid arthritis, systemic lupus erythematosus
•5) Patients diagnosed as Charcot–Marie–Tooth disease or sickle cell disesase
•6) Patients with chronic wasting disease who are not currently being treated
•7) Patients had poor prognosis diseases including malignant tumors
•8) Patients had corticosteroids, immunosuppressants, radiation therapy or chemotherapy
•9) Patients with hypersensitivity to the constituents of the substance or storage solution used in the manufacturing process
•10) Patients known hypersensitivity to bovine-derived components
•11) Patients had mental disorder, drugs or alcohol addiction and could not understand the present study
•12) Patients whose life is short
•13) If the use of a prohibited drug is anticipated during the trial period
•14) If patients are taking medicines for other clinical trials within 30 days of participating in this clinical trial
•15) Patients not suitable for research based on the researcher’s decision

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