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

Sponsor

Guili Wang (Other)

Overall Status

Recruiting

CT.gov ID

NCT06014437

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot	Drug: PLCL/Fg group Drug: control group	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material Poly (L-lactide-co-caprolactone) and Formulated Porcine Fibrinogen

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PLCL/Fg Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds.	Drug: PLCL/Fg group Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds. Other Names: PLCL/Fg dressing
Active Comparator: control group Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds.	Drug: control group Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds Other Names: alginate dressing

Arm

Intervention/Treatment

Experimental: PLCL/Fg

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

Drug: PLCL/Fg group

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

Other Names:

PLCL/Fg dressing

Active Comparator: control group

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

Drug: control group

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

Other Names:

alginate dressing

Outcome Measures

Primary Outcome Measures

Incidence of complete wound closure during treatment and follow-up (12 weeks). (Outpatient follow-up 2-3 times per week, standardized photographs and measurement of wound size) [12 weeks]
Complete healing is defined as complete re-epithelialization of the ulcer bed with no discharge. Speed of healing is calculated by measuring the size or percentage reduction in wound area per week.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Vascular Surgery, Jinshan Hospital, Fudan University	Shanghai		China

Sponsors and Collaborators

Guili Wang

Investigators

Study Chair: zhihui dong, Department of Vascular Surgery, Jinshan Hospital, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guili Wang, Jinshan hospital Fudan University. Guili Wang is Principal Investigator of vascular surgery, Fudan University

ClinicalTrials.gov Identifier:

NCT06014437

Other Study ID Numbers:

Jinshan hospital

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetic Foot

Study Results

No Results Posted as of Aug 28, 2023