Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material PLCL/Fg

Guili Wang

Status and phase: Enrolling; Phase 4

Conditions: Diabetic Foot

Treatments: Drug: control group; Drug: PLCL/Fg group

Study type: Interventional

Funder types: Other

Identifiers

NCT06014437

Jinshan hospital

Details and patient eligibility

About

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 SCIE paper. Provide a large amount of data support for the application of PLCL/Fg dressing in diabetic foot ulcer wound repair through basic experimental and clinical experimental studies. It can provide a practical and effective biomaterial for the treatment of clinical skin wound structure and function reconstruction, make the patient's wound healing as soon as possible, benefit the general public, reduce medical expenditure, reduce the burden on the society, lay the foundation for the industrialization and marketization of national innovative medical devices, and help to improve the international status and value of the application.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

PLCL/Fg

Experimental group

Description:

Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds.

Treatment:

Drug: PLCL/Fg group

control group

Active Comparator group

Description:

Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds.

Treatment:

Drug: control group