A clinical study on the improvement of inflammatory response around the wound in diabetic foot with encircling paste
- Conditions
- diabetic foot
- Registration Number
- ITMCTR2200006147
- Lead Sponsor
- Dongzhimen Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1)Aged between 18 and 80 years old (inclusive), male and female;(2)Western medical diagnostic criteria consistent with diabetic foot;(3)Compliant with Diabetic Foot Infection (IDSA classification) grade 2-3,Ankle-brachial index = 0.7;(4)Glycated haemoglobin=8%;(5)Meets the criteria for the identification of diabetic foot ulcers in Chinese medicine as Yang evidence;(6)The patient gives informed consent and signs an informed consent form..
(1)Allergy or hypersensitivity to the test drug, its components or the control drug;(2) Serum albumin <25g/L, haemoglobin <90g/L, platelets <100 x 10^9/L;(3)Pregnant or planning to have a baby within 3 months, or pregnant or breastfeeding women;(4)Participants who have participated in a clinical study within 1 month prior to enrolment;(5)Severe cardiac, hepatic or renal insufficiency that seriously compromises the safety and treatment of the subject.In the judgment of the investigator, the patient is unable to complete the study or to comply with the requirements of the study;(6)Expected ulcer site debridement, percutaneous transluminal angioplasty (PTA) within 7 days prior to trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method