Regeneration of skin defects in diabetic ulcers using new electrospun material
Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material Poly (L-lactide-co-caprolactone) and Formulated Porcine Fibrinogen
This study is testing a new type of dressing to see if it can help heal diabetic foot ulcers better than standard treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06014437 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of PLCL/Fg dressings in treating diabetic foot ulcers through a prospective cohort approach. It aims to gather extensive real-world data to evaluate how these innovative dressings can enhance wound healing and improve skin structure and function. The study includes a control group for comparison and focuses on patients with chronic ulcers to assess the potential benefits of this new biomaterial. The ultimate goal is to provide a practical solution that can reduce healthcare costs and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with type 1 or type 2 diabetes and chronic ulcers that have persisted for more than 4 weeks.
Not a fit: Patients with infections, osteomyelitis, or other conditions that impair wound healing will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly accelerate wound healing in patients with diabetic foot ulcers.
How similar studies have performed: Other studies have shown promise with similar biomaterials in wound healing, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Department of Vascular Surgery, Jinshan Hospital, Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: guili wang
- Email: wgl4611@126.com
- Phone: +8618264188121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.