Foot ulcers of difficult-to-heal nerve injury
Conditions
Interventions
Control group:Basic treatment
Experimental group:Basic treatment+AVBER repair microemulsion
Sponsors
The First Affiliated Hospital, Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older, and less than 65 years old, gender is not limited; 2.The target ulcer should persist for at least 4 weeks before enrollment; if there are multiple lesions, the ulcer area with the largest area below the ankle joint should be selected as the target ulcer; 3.The target ulcer can be measured, and the area of the target ulcer after debridement is 1cm2 or less than 40cm2 (measured after debridement); if there is an infection, the infection at baseline should be effectively controlled (judged by the investigator); 4.Stable control of blood glucose after treatment (glycated hemoglobin HbA1c 6 and <= 12, and/or reduced muscle electrical conduction velocity (MCV or SCV) of the lower limb nerves (tibial nerve, common peroneal nerve, sural nerve) to more than 75% of normal values, and/or decreased amplitude (CMAP or SNAP); 7.Willing and able to follow the treatment and visitation as prescribed by the study protocol.
Exclusion criteria
Exclusion criteria: 1.Breastfeeding or pregnant women or women of childbearing age with positive pregnancy test, or unwilling to take effective contraceptive measures from the time of the test until 3 months after the last medication; 2.People who are allergic to the product or its components; 3.X-ray plain film examination of patients with combined osteomyelitis, or clinical (or radiological) diagnosis of Charcot's neurogenic arthropathy; 4.Patients with ulcers, sinus tracts due to other lesions, or other reasons that prevent debridement; 5.The researchers judged the suspected cancerous area of the ulcer according to the ulcer condition; 6.Severe hypertension that remains uncontrolled after drug therapy (3 months): systolic blood pressure = 160mmHg or diastolic blood pressure >=100mmHg; 7.Patients with severe lower extremity ischemia (ankle brachial index ABI 2.5 times ULN or AST> 2.5 times ULN or TBil> 1.5 times ULN; Cr> 1.5 times ULN or GFR> 2.5 times ULN; 11.Malnourished (hemoglobin <60g/L; albumin <25g/L or total protein <60g/L); 12.History of malignant tumor in the previous 5 years; 13.Clinical investigators who have participated in other new drugs or medical devices within the previous 3 months; 14.Investigators who are unable to complete the study due to serious mental or language disorders; 15.Researchers are not considered suitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to ulcer healing;The change in the Michigan Diabetes Neuropathy Score (MDNS) (for the affected limb) at each visit point compared to the baseline.;At the end of treatment, the conduction velocity (MCV and SCV) and amplitude (CMAP and SNAP) of the tibial nerve, common peroneal nerve, and sural nerve of the affected lower limb were compared with those at baseline;At the end of treatment, the percentage of subjects whose conduction velocity (MCV and SCV) and amplitude (CMAP and SNAP) of tibial nerve, common peroneal nerve and sural nerve of the affected lower limb increased by 20% and 50%, respectively;Proportion of subjects with complete healing of target ulcers in each group at the end of treatment;Duration of treatment for those with a target ulcer surface area reduction of >=50%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinalysis;Vital Signs Measurement;Blood Pregnancy Test;Possible adverse events (such as wound and skin observation, etc.) and the incidence of adverse reactions;Electrocardiographic examination;Changes in VAS scores for wound pain at each visit point compared to baseline;Blood routine examination;Kidney function test;C-reactive protein test(CRP);Liver function test?;Changes in ulcer area at each visit point compared to baseline; | — |
Countries
China
Contacts
Public ContactXiaofei Zheng
The First Affiliated Hospital, Jinan University
Outcome results
None listed