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Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial

Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05975827
Enrollment
28
Registered
2023-08-04
Start date
2024-05-01
Completion date
2025-04-30
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ulcers, Diabetic Ulcers in Necrosis Stable Stage

Keywords

Diabetic Ulcers

Brief 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. 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.

Interventions

DEVICESterile Wound Care Liquid Dressing

Sterile wound care liquid dressing is used in the wound treatment

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected. 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

Design outcomes

Primary

MeasureTime frame
2-week reduction rate of wound area2-week

Secondary

MeasureTime frame
2-week wound healing rate2-week

Contacts

Primary ContactLong Zhang, MD
longzh2000@163.com+86 010-82266699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026