Diabetic foot ulcers
Conditions
Interventions
Diabetic foot ulcer non-healing group:none
Group of diabetics without ulcers:none
Diabetic foot ulcer healing group:none
Sponsors
Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, China
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the infected diabetic foot ulcer group (1) Age = 40 years and = 80 years, regardless of gender; (2) Duration of foot ulcer = 4 weeks; (3) Duration of diabetes mellitus >10 years; (4) Ulcer area 6-20cm2; (5) Wagner grade 2-4; (6) IWGDF/IDSA PEDIS infection grade 2-3; (7) Bacterial culture of the ulcer tissue had been performed before enrolment, and the bacterial culture results were MRSA and Escherichia coli, and it was proposed to perform foot chemoembolisation and debridement in our hospital; (8) Meet the diagnostic criteria of biofilm; (9) Possess at least 2 of the signs/symptoms in the TCM evidence type of blood stasis. Inclusion criteria for diabetic patients with no history of ulcer disease (1) Age =40 years and =80 years, gender is not limited; (2) Patients with type 2 diabetes mellitus without history of foot ulcers; (3) No other chronic diseases or history of foot surgery. (3) Patients who intend to undergo excision of skin mass (lipoma, nevus) / foot orthopaedic surgery in our clinic
Exclusion criteria
Exclusion criteria: Exclusion criteria for infected diabetic foot ulcer group (1) Presence of disease complications affecting DFU healing: e.g. tumours, vasculitis, immune system disorders, etc., or diagnosis of severe hepatic dysfunction, end-stage renal disease, prolonged treatment with radiotherapy, chemotherapy, and growth factor medications, and poor blood supply status; (2) Diagnosis of clinical signs of acute infection according to IDSA/IWGDF, osteomyelitis associated with DFU, or receipt of topical or systemic antimicrobial therapy 2 weeks prior to study inclusion. Patients with acute clinical infections were excluded because studies have shown that the behaviour of these wounds will be primarily driven by plankton; (3) Foot ulcers caused by something other than diabetes; (4) Study participants with severe hypertension (hypertensive crisis or malignant hypertension), cardiovascular disease (e.g., cardiac class IV, sequelae of severe cerebrovascular disease), and patients diagnosed with acute infections and infectious diseases. Exclusion criteria for the group of diabetic patients with no history of ulcer disease (1) Taking medication within one month prior to participation in the study; (2) Study participants who have undergone other surgeries on the foot; (3) Diagnosis of other diseases such as diabetic foot, chronic hypertension, kidney disease, cardiopulmonary disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound size;Validation of the expression of molecules associated with differential protein and metabolite enrichment pathways; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differential protein and metabolites; | — |
Countries
China
Contacts
Public ContactFulun Li
Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed