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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

NCT04040426

Diabetic Foot Ulcer Foot

COMPLETED NA

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

NCT07086443

Diabetic Foot Ulcer DFU Diabetic Foot Ulcer (DFU) +4 more

RECRUITING PHASE4

A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

NCT01270633

Foot Ulcer, Diabetic

TERMINATED NA

Platelet Rich Plasma and Diabetic Foot Ulcer

NCT04750837

Platelet Rich Plasma

COMPLETED PHASE2

Plasma and Scarring of Diabetic Ulcers

NCT04145154

Chronic Skin Ulcer Diabetic Foot Plasma Protein; Transport Protein

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PLCL/Fg

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

Group Type EXPERIMENTAL

PLCL/Fg group

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PLCL/Fg group

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PLCL/Fg dressing alginate dressing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No