Status:
UNKNOWN
Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material PLCL/Fg
Lead Sponsor:
Guili Wang
Conditions:
Diabetic Foot
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Prospective cohort studies through clinical trials. Obtained a large amount of real-world data to explore the efficacy of PLCL/Fg dressings for specific clinical applications. Published 1 relevant SC...
Eligibility Criteria
Inclusion
- Age between 18 and 90 years; type 1 or type 2 diabetes mellitus; history of ulceration for more than 4 weeks at enrollment; wound area between 1 and 25 square centimeters; wound depth of Wagner grades 1 and 2; and an ABI of 0.7 to 1.3 on the affected lower extremity or a transcutaneous oxygen pressure of greater than or equal to 30 mmHg.
Exclusion
- Wound healing percentage greater than 30% during wound preparation (7 days); any infection, osteomyelitis, or other condition that may affect wound healing, such as deep vein thrombosis, rheumatoid arthritis, systemic lupus erythematosus, or any other systemic inflammatory disease.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06014437
Start Date
March 1 2023
End Date
March 31 2024
Last Update
August 28 2023
Active Locations (1)
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1
Department of Vascular Surgery, Jinshan Hospital, Fudan University
Shanghai, China