NCT06014437

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 17, 2023

Last Update Submit

August 23, 2023

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • 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)

    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.

    12 weeks

Study Arms (2)

PLCL/Fg

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

PLCL/Fg groupDRUG

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

Also known as: PLCL/Fg dressing
PLCL/Fg
control groupDRUG

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

Also known as: alginate dressing
control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Vascular Surgery, Jinshan Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (1)

  • Wang G, Li X, Ju S, Li Y, Li W, He H, Cai Y, Dong Z, Fu W. Effect of electrospun poly (L-lactide-co-caprolactone) and formulated porcine fibrinogen for diabetic foot ulcers. Eur J Pharm Sci. 2024 Jul 1;198:106800. doi: 10.1016/j.ejps.2024.106800. Epub 2024 May 14.

    PMID: 38754593DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • zhihui dong

    Department of Vascular Surgery, Jinshan Hospital, Fudan University

    STUDY CHAIR

Central Study Contacts

guili wang

CONTACT

+8618264188121wgl4611@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Jinshan hospital Fudan University. Guili Wang is Principal Investigator of vascular surgery

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 28, 2023

Study Start

March 1, 2023

Primary Completion

January 31, 2024

Study Completion

March 31, 2024

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Data will be made available on request.

Locations

CN(1)