Diabetic UlcersNCT05975827
Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
A study testing Sterile Wound Care Liquid Dressing in people with Diabetic Ulcers and Diabetic Ulcers in Necrosis Stable Stage, run by Peking University Third Hospital.
Trial summary
This study aimed to investigate methods for promoting infection control, reducing tissue edema, and preventing excessive spread in diabetes foot ulcers in the necrosis stable stage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Ulcers, Diabetic Ulcers in Necrosis Stable Stage
- What is being tested?
- Sterile Wound Care Liquid Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Apr 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected.
- Poor glycemic control; fasting blood glucose >15mmol/L; glycosylated hemoglobin >12%.
- Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
- Serum albumin <20g/L; hemoglobin <60g/L; platelets <50×10^9/L
- Advanced malignant tumor patients
- Autoimmune disease activity period
Show all 13Show fewer
- History of allergy to aseptic wound care liquid dressing
- Patient unable to cooperate or has mental disorders
- Pregnant and lactating women
- Eye injuries and natural cavities such as ear canal, nasal cavity or abdominal cavity
- Skin tumors
- Active skin diseases
- According to the researcher's judgment, patients who clearly have factors affecting wound healing that cannot be removed are not suitable for this study or cannot comply with the requirements of this study
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
This study aimed to investigate methods for promoting infection control, reducing tissue edema, and preventing excessive spread in diabetes foot ulcers in the necrosis stable stage. Additionally, it sought to explore potential indications for the use of aseptic wound care liquid dressings in these ulcers, with the goal of obtaining evidence-based medical data on their clinical efficacy.
Participants will be assigned with a 1:1 ratio into intervention group and control group.
Participants in the intervention group will be irrigated with sterile liquid dressing for each wound treatment on the basis of clinical standard treatment protocols for 2 weeks, until the end of the 2-week observation period. Participants in the control group will be irrigated with normal saline for each wound treatment for 2 weeks on the basis of the clinical standard diagnosis and treatment plan, until the end of the 2-week observation period.
- Being tested
- Sterile Wound Care Liquid Dressing
- Keywords
- Diabetic Ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile Wound Care Liquid DressingDevice
Sterile wound care liquid dressing is used in the wound treatment
| Study group | Role | What they receive |
|---|---|---|
| Sterile Wound Care Liquid Dressing | Experimental | Not described Receives: Device: Sterile Wound Care Liquid Dressing |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-week reduction rate of wound area
Measured: 2-week
Secondary outcomes (1)
2-week wound healing rate
Measured: 2-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic UlcersStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975827
- Sponsor's protocol ID
- Long2024-DFU-Sterile dressing
- Status last verified
- Apr 2024
- First submitted
- 27 Jul 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05975827
- Acronym / sponsor ID
- Long2024-DFU-Sterile dressing
- Keywords
- Diabetic Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 4 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.
This study aimed to investigate methods for promoting infection control, reducing tissue edema, and preventing excessive spread in diabetes foot ulcers in the necrosis stable stage. Additionally, it sought to explore potential indications for the use of aseptic wound care liquid dressings in these ulcers, with the goal of obtaining evidence-based medical data on their clinical efficacy.
Participants will be assigned with a 1:1 ratio into intervention group and control group.
Participants in the intervention group will be irrigated with sterile liquid dressing for each wound treatment on the basis of clinical standard treatment protocols for 2 weeks, until the end of the 2-week observation period. Participants in the control group will be irrigated with normal saline for each wound treatment for 2 weeks on the basis of the clinical standard diagnosis and treatment plan, until the end of the 2-week observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile Wound Care Liquid Dressing | Experimental | Device: Sterile Wound Care Liquid Dressing |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected.
- Poor glycemic control; fasting blood glucose >15mmol/L; glycosylated hemoglobin >12%.
- Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
- Serum albumin <20g/L; hemoglobin <60g/L; platelets <50×10^9/L
- Advanced malignant tumor patients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sterile Wound Care Liquid DressingSterile wound care liquid dressing is used in the wound treatment | Device | Sterile Wound Care Liquid Dressing |
Primary outcome
2-week reduction rate of wound area
Time frame: 2-week
1 secondary outcome
2-week wound healing rate
Time frame: 2-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Wound Care Liquid Dressing in people with Diabetic Ulcers and Diabetic Ulcers in Necrosis Stable Stage, run by Peking University Third Hospital.
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 13 inclusion and 0 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Long Zhang, MD (+86 010-82266699, longzh2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-week reduction rate of wound area (time frame: 2-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2024.