Diabetic FootPhase 4NCT06014437
Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material PLCL/Fg
A Phase 4 study testing PLCL/Fg group in people with Diabetic Foot, run by Guili Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- PLCL/Fg group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery, Jinshan Hospital, Fudan University
Shanghai
guili wang, +8618264188121, wgl4611@126.com
About this study
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
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.
- Conditions
- Diabetic Foot
- Being tested
- PLCL/Fg group, control group
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLCL/Fg groupDrug
Also called PLCL/Fg dressing
Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds.
control groupDrug
Also called alginate dressing
Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds
| Study group | Role | What they receive |
|---|---|---|
| PLCL/Fg | Experimental | Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds. Receives: 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. Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Mar 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guili Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guili Wang, Fudan University
- Investigators
- zhihui dong, Study chair, Department of Vascular Surgery, Jinshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014437
- Sponsor's protocol ID
- Jinshan hospital
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available on request.
Publications
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.
PubMed 38754593
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06014437
- Acronym / sponsor ID
- Jinshan hospital
- Conditions
- Diabetic Foot
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Guili WangUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLCL/Fg | Experimental | Drug: PLCL/Fg groupRoutine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds. |
| control group | Active comparator | Drug: control groupRoutine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLCL/Fg groupAlso: PLCL/Fg dressingRoutine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds. | Drug | PLCL/Fg |
| control groupAlso: alginate dressingRoutine 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 |
Primary outcome
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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Derived from this study: PubMed 38754593Wang 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.
- Individual participant dataSharing planned: No. Data will be made available on request.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhihui dong study chair
Department of Vascular Surgery, Jinshan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PLCL/Fg group in people with Diabetic Foot, run by Guili Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact guili wang (+8618264188121, wgl4611@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06014437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.