Chronic refractory wound
Conditions
Interventions
Experimental group:Lipid bismuth tribromophenol dressing
Control group:Medical vaseline gauze
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old (including 18 and 75 years old), male or female; (2) Patients who meet the diagnostic criteria of diabetic foot ulcer, chronic wounds (wounds that did not heal after 4 weeks of regular treatment), Wagner grade I, and infected IDSA grade II; (3) Fasting blood glucose =10mmol/L should be controlled according to the medical records and maintained at this level for more than 2 weeks; (4) The ulcer area of the target wound is 1-30cm2. If there was more than one ulcer, the latest ulcer wound should be selected as the target test area. (5) The test site should be located in the extremities (isolated wounds were selected as the test area as far as possible). (6) Informed consent should be obtained from all subjects.
Exclusion criteria
Exclusion criteria: (1) Contraindication to the use of the study product or its components (vaseline, bismuth tribromophenol, paraffin, etc.) or a history of allergy to bismuth; (2) Ulcers caused by other causes, such as tumors, infectious diseases, etc. (3) Complicated with severe heart, liver and kidney diseases (heart function = grade 3, alanine aminotransferase > 2.5 times normal, albumin 1.5 times normal), severe systemic infection, acute metabolic disorder, severe immune system diseases; (4) Severe malnutrition (nutritional assessment scale MUST be greater than 1); (5) Pregnant and lactating women; (6) Had participated in other clinical investigators within 3 months before participating in this study; (7) Other conditions considered by the physician to be inappropriate for enrollment, such as poor compliance or being terminally ill or unable to complete the course of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of patients with wound healing;Patient satisfaction (odor); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of wound healing;Wound reduction rate at 2, 4, 6, and 8 weeks;Change in IDSA grade (or proportion of patients achieving grade 1);Visual analogue scale (VAS) of pain (2, 4, 6, 8 weeks);Proportion of patients treated with rescue antibiotics; | — |
Countries
China
Contacts
Public ContactJu Shang
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed