diabetes foot uclers
Conditions
Interventions
fish oil group:fish oil
Corn oil group:Corn oil
Sponsors
Second Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) It meets the diagnostic criteria for diabetes proposed by WHO in 1999; (2) Age range: 18 to 70 years old; (3) Glycosylated hemoglobin HbA1c < 12%; (4) Wagner grading is between 1 and 3 levels; (5) At least one ulcer below the ankle, with a duration of at least one month and an area of = 1 cm2; (6) The ankle brachial index is 0.7 to 1.2; Or the back percutaneous oxygen test result is = 30 mmHg; Or the Doppler arterial waveform at the ankle is biphasic or better; (7) No treatment such as corticosteroids, antioxidants, or fish oil preparations has been received within the past three months; (8) Patients with a clear infection can be included in the study after infection control, i.e., after procalcitonin is reduced to normal.
Exclusion criteria
Exclusion criteria: (1) Allergies to any component in supplements; (2) Active Charcot neuroarthrosis; (3) Patients with malignant tumors or undergoing radiotherapy or chemotherapy due to tumors; (4) Known immunosuppressive diseases or receiving immunosuppressive treatment; (5) Collagen vascular disease or autoimmune disease; (6) Renal function impairment (blood urea nitrogen>21.4 mmol/l, creatinine>247.5 µ Mol/l), liver failure/cirrhosis (Child B or C), myocardial infarction; (7) In the past 2 weeks, they have received similar treatment such as bioengineered tissue or growth factors, or received treatment such as collagen or negative pressure suction that may affect the research results; (8) Pregnant or lactating women; (9) Patients with a history of mental illness who are unable to cooperate with this project study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a reduction in wound area = 50% within the 12th week;Proportion of subjects with complete ulcer healing at the 12th week (complete closure of the wound without drainage).;Percentage reduction in ulcer area at weeks 12 compared to week 0, with calculation of the mean for each group;Healing time: from the start of the study until wound healing or the end of observation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum inflammatory markers: IL-6, IL-8, TNF-a, hs-CRP;;Blood routine, neutrophil/lymphocyte ratio (NLR), and platelet/lymphocyte ratio (PLR);;Incidence of wound reinfection; | — |
Countries
China
Contacts
Public ContactWang Jian
Second Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed