Phase II clinical trial on effectiveness of synthetic bilayer scaffold composed of amniotic membrane and silk fibroin in Wagner ulcers II in comparison with amniotic membrane

Deputy of Research and Technology of Avicenna Research Institute0 个研究点目标入组 20 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

暂无简介。

•diagnosed with diabetes; within the age range of 18 to 60 years; wound area between 1 to 20 square centimeter; one month passed wound creation
•Exclusion criteria: simultaneous wound infection (active cellulite, osteomyelitis, sinus infection, etc.); more than 50% wound healing in one month period prior to intervention; simultaneous diagnosis with metastatic diseases or malignant diseases, especially those involving hematologic system or bone; receiving chemotherapy or immunosuppressive medications; simultaneous diagnosis with an autoimmune disease such as chronic lymphocytic thyroiditis, arthritis rheumatoid, and lupus; administration of therapeutic agents containing growth factors; hemoglobin level of less than 10 mg/dl or thrombocytopenia (platelets of less than 100,000); serum albumin level of less than 2.5 g/dl; records of vascular surgery in 3 months period prior to intervention; addiction to oral or injectable narcotic drugs; diagnosis with any systemic disease which would interfere with the process of wound healing; pregnancy, breastfeeding; history of vascular disorders or neuropathy; history of diagnosis with hematologic disorders; diagnosis with any conditions requiring treatment such as gangrene; application of injectable, oral antibiotic in 48 hours prior to intervention; patient participation in other clinical trials in three months pre-intervention; no disruption in blood circulation to the wounded region

发起方

Deputy of Research and Technology of Avicenna Research Institute