Comparison of effects of Hydrofiber foam (Aquacell foam®) and povidone-iodine foam (Betafoam®) on diabetic foot ulcer; prospective randomized study

Catholic Kwandong University International St.Mary's Hospital0 个研究点目标入组 70 人开始时间: 待定最近更新: 2023年1月10日

适应症

试验速览

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•1) Male and female patients aged 18 years or older
•2) Patients consented to clinical plan and clinical follow-up, and who gave consent in written form approved by the Institutional Review Board
•3) Patients with diabetic foot ulcers who have all of the following
•- Target ulcer present below the ankle (If two or more ulcer lesions exist, the largest ulcer is considered the target ulcer. If there are ulcers of the same size, the ulcer with a higher Wagner grade is considered the target ulcer.)
•- Wagner Grade I or II
•- Patients with ulcers larger than 1*1cm2 (length*width) after debridement

•1) Patients consented to clinical plan and clinical follow-up, and did not consent to the written approval of the Institutional Review Board
•2) Pregnant or breast feeding women
•3) Patients with hypersensitivity to povidone-iodine, a medical device for clinical trials
•4) Hyperthyroidism patients or other thyroid dysfunction patients(nodular goiter, endemic goiter, Hashimoto's thyroiditis, etc.) or those receiving radioactive iodine treatment
•5) Those who are participating in other interventional studies at the time of registration
•6) Those with comorbidities that may affect wound healing; Malignant tumor, vasculitis, connective tissue disease, etc.
•7) Patients with immunosuppression(chemotherapy, End-stage renal disease undergoing dialysis or requiring dialysis, patients with a history of previous renal transplantation or receiving specific immunosuppressants, etc.)

发起方

Catholic Kwandong University International St.Mary's Hospital