Chronic refractory wound of lower extremity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Chronic wounds in the lower extremities (defined as the inability to heal orderly and timely within 1-2 months, resulting in anatomical and functional integrity), adults aged 18 to 80 years; 2) All types of chronic wounds, including venous ulcers (VU), diabetic foot ulcers (DFU), pressure ulcers (PU), traumatic ulcers, etc.; 3) ABI index >= 0.9 and =0.5cm2 and <=22cm2; 5) Able to comply with weekly visits to the wound and stoma clinic; 6) Able to perform microcurrent therapy at home every day; 7) Agree to participate in and sign the informed consent form for clinical research.
Exclusion criteria
Exclusion criteria: 1) Have used any microcurrent device within 6 months before the study; 2) the presence of electrical implants, such as pacemakers or neurostimulators; 3) Leg circumference or obesity (BMI > 34) not suitable for common peroneal nerve electrical stimulation equipment; 4) Malignant tumor receiving treatment or any other malignant tumor (whether in remission) involving the musculoskeletal system; 5) Suffering from multiple organ failure; 6) Systemic metabolic diseases and systemic infectious diseases; 7) Severe cognitive impairment, language impairment and non-cooperation with treatment; 8) Photocutaneous disease and systemic lupus erythematosus; 9) Severe hypertension (systolic blood pressure>180mm Hg, diastolic blood pressure>120mm Hg); 10) History of obvious blood disease or deep vein thrombosis or coagulation dysfunction or recent use of anticoagulants in the previous 6 months; 11) Acute dysplasia; 12) Patients receiving immunosuppressants, hormones and other drugs that affect wound healing; 13) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area reduction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bates-Jensen Wound Status Score (BWAT);Visual Analogue Pain (VAS) Score;Lower extremity chronic wound quality of life rating scale WOUND-QOL;Quality of Life Questionnaire for Patients with Lower Extremity Venous Ulcers (VLU-QOL);Midkine;Wound microbes; | — |
Countries
China
Contacts
The Affiliated JiangSu Shengze Hospital of Nanjing Medical University