Study on evidence-based evaluation and therapeutic mechanism of integrated Chinese and Western medicine for treatment of diabetic foot -- An evidence-based evaluation of The combination of Rubber Shengji Paste and compound bromelain to promote the healing of the exposed wound of diabetic foot tendon

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•Those who do not meet any of the following criteria will not be included in this study
•(1) Patients who meet the diagnostic criteria for diabetic foot diseases and Wagner grades 3-4 injuries and tendon tissues;
•(2) Between the ages of 18 and 85, male or female;
•(3) Fasting blood glucose <= 10mmol/L;
•(4) Target ulcer debridement area is between 1 and 20 cm2 (for patients with multiple lesions, the area with the largest ulcer is selected as the target lesion);
•(5) The ratio of ankle/brachial artery blood pressure on the ulcer side limb is >= 0.5;
•(6) The wound has new blood supply or ooze, pus or secretions are sticky;
•(7) Participate in this experiment voluntarily and sign informed consent.

•Those who meet any of the following criteria will not be included in this study
•(1) Skin ulcers and malignant lesions in ulcer caused by electrical, chemical, radioactive, neoplastic, varicose veins and other reasons;
•(2) Severe clinical infection, such as cellulitis, fever or elevated white blood cells in blood routine, or bacterial culture or detection (hypersensitivity) of C-reactive protein indicated the presence of infected persons at the lesion site of the ulcer;
•(3) With severe uncontrolled hypertension, systolic blood pressure >= 160mmHg or diastolic blood pressure >= 110mmHg;
•(4) Serum albumin < 28g/L;
•(5) Hemoglobin < 90g/L;
•(6) Platelet < 50 x 10^9/L;
•(7) For patients with severe heart, liver and kidney injuries, those requiring medical treatment or those seriously affecting the safety and treatment of the subjects, the researcher shall decide whether to exclude them;
•(8) those who have pregnancy or family planning, or women who are pregnant or lactating;
•(9) People with cognitive dysfunction who cannot give full informed consent;
•(10) Persons with allergic constitution or known allergy to the ingredients of test drugs and control drugs;
•(11) Participate in other clinical trials within the past 1 month;
•(12) According to the judgment of the researcher, the patient cannot complete the study or comply with the requirements of the study.

发起方

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine