Chronic wounds or ulcers of the lower extremities
Conditions
Interventions
Control group (negative pressure therapy group):Perform wound debridement and installation of negative pressure therapy devices according to standard procedures
Pilot group (electric field coupled negative pressure integrated treatment group):Perform wound debridement and installation of electric field coupled negative pressure integrated treatment device acc
Sponsors
the First Affiliated Hospital of Army Medical Universiy,PLA
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Voluntary participation in the study and signing the informed consent form; 2) Age between 60 and 80 years old; (3) Patients diagnosed with diabetic lower limb ulcers (LEDUS) or lower limb arterial ulcers (LEAUS) with a disease duration of more than 4 weeks and no tendency to heal spontaneously; (4) Patients with a wound area of =6cm2 and =25cm2, with no obvious necrotic tissue remaining and no deep tendons, nerves, blood vessels or bone exposed; (5) The glycosylated haemoglobin (HbA1c) of the patients was controlled within 10% at the time of enrolment; (6) The patient's ankle-brachial index (ABI) is more than 0.7.
Exclusion criteria
Exclusion criteria: 1) Patients with definite malignant tumours, AIDS or autoimmune diseases; 2) Patients with definite severe cardiac, pulmonary, haematological or neurological diseases; 3) Patients with haemoglobin (HB) <90g/L; 4) Patients with albumin <25g/L; 5) Patients with severe peritraumatic infections; 6) Patients with combined sepsis or systemic multi-organ failure; 7) Those who have participated and are participating in other clinical studies within 3 months; 8) those with poor compliance and difficulty in completing the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of wounds healed at day 14 post-treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound granulation coverage;Degree of inflammatory response at the trabecular margin;Rate of wound healing;Wound healing rate; | — |
Countries
CHINA
Contacts
Public ContactZhang Jiaping
the First Affiliated Hospital of Army Medical Universiy,PLA
Outcome results
None listed