diabetic foot
Conditions
Interventions
Test group:encircling paste
Control group:nothing
Sponsors
Dongzhimen Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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..
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain of Infiltration zone around the wound;Swelling of Infiltration zone around the wound;Scope of debridement;Infection level;Culture of secretions;Wound healing time;Colour of Infiltration zone around the wound;Temperature of Infiltration zone around the wound;Trauma depth reduction rate;Wound healing rate;Amount of granulation tissue, flesh and scab on the wound; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibiotic use;Overall efficacy assessment criteria;Amputation rate;Inflammatory indicators; | — |
Countries
China
Contacts
Public ContactJuShang
Outcome results
None listed