Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
NCT ID: NCT05975827
Last Updated: 2024-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
28 participants
INTERVENTIONAL
2024-05-01
2025-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Sterile Wound Care Liquid Dressing
Sterile Wound Care Liquid Dressing
Sterile wound care liquid dressing is used in the wound treatment
Control
No interventions assigned to this group
Interventions
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Sterile Wound Care Liquid Dressing
Sterile wound care liquid dressing is used in the wound treatment
Eligibility Criteria
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Inclusion Criteria
2. Poor glycemic control; fasting blood glucose \>15mmol/L; glycosylated hemoglobin \>12%.
3. Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
4. Serum albumin \<20g/L; hemoglobin \<60g/L; platelets \<50×10\^9/L
5. Advanced malignant tumor patients
6. Autoimmune disease activity period
7. History of allergy to aseptic wound care liquid dressing
8. Patient unable to cooperate or has mental disorders
9. Pregnant and lactating women
10. Eye injuries and natural cavities such as ear canal, nasal cavity or abdominal cavity
11. Skin tumors
12. Active skin diseases
13. 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
18 Years
80 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Long Zhang
Professor
Central Contacts
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Other Identifiers
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Long2024-DFU-Sterile dressing
Identifier Type: -
Identifier Source: org_study_id
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