diabetic foot ulcers
Conditions
Interventions
ultrasound-guided continuous parasacral ischial plane block+SOC group:ultrasound-guided continuous parasacral ischial plane block+SOC
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 89 Years
Inclusion criteria
Inclusion criteria: 1.Written informed consent was signed prior to the first study evaluation; 2.Males and females aged between 18 and 89 years; 3.Documented diagnosis of type 1 or 2 diabetes Foot ulcer at or below ankle with duration >4 weeks to 30 days; B.If>1 ulcer is present, largest is considered as the study index ulcer; C.Index ulcer must be >1 cm from any other ulcers ; 4.present on the foot Ulcer size >1 cm^2 and =20 cm^2 after debridement at start of run-in period; 5.Ulcer of UTC grade 1A, 1B, 1C, 1D, 2A, 2B, 2C, or 2D; 6.ABl >0.7 with a TcP0,>30 mmHg, skin perfusion >30 mmHg, toepressure >30 mmHg, or Duplex ultrasound with biphasic waveforms below the knee; 7.No planned revascularization procedure or vascular surgery within the last or next 30 days; 8.Subject and caregiver willing and able to comply with all specified careand visit requirements; 9.Subject has a reasonable expectation of completing the study; 10.Subject completed 2-week run-in period with <30% wound sizereduction.
Exclusion criteria
Exclusion criteria: 1.Evidence of gangrene on any part of affected limb; 2.Documented evidence of osteomyelitis on any part of affected limb; 3.Index ulcer has exposed bone 4.Active Charcot foot on the study limb 5.Uncontrolled diabetes: HbA>12% (108 mmol/mol); 6.Renal dialysis or creatinine >2.5 mg/dL (221 µmol/L); 7.Known immune insufficiency; 8.Active treatment for malignancy (not specific to study limb); 9.Chronic steroid use or immunosuppressive agents within the last 3 months or anticipated to require them during the duration of the study; 10.Subject participated in another investigational device, drug, or biologicaltrial within last 30 days; 11.Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention; 12.Subject is pregnant at the time of screening; 13.Subject has had a deep vein thrombosis within the last 30 days; 14.Subject has received growth factor therapy, autologous platelet-richplasma gel, bilayered cell therapy, dermal substitute, extracellularmatrix, etc., within the screening period; 15.Due to other reasons, the researcher determined that it is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of complete healing of the target ulcer at 12 weeks in both groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for ulcer to heal completely;Percentage change in ulcer surface area from baseline;Percentage of subjects with a 50% reduction in ulcer area;Percentage of subjects with recurrent ulcers;Incidence of target ulcer infection;Pain score during treatment;Evaluation of lower limb hemodynamics;Detection of ulcer wound tissue angiogenesis and other indicators;Cardiff Wound Impact Schedule (CWIS) QOL index for Wound care; | — |
Countries
China
Contacts
Public ContactTing Zheng
Department of Anesthesiology, Fujian Provincial Hospital
Outcome results
None listed