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

Peking University

Status: Not yet enrolling

Conditions: Diabetic Ulcers; Diabetic Ulcers in Necrosis Stable Stage

Treatments: Device: Sterile Wound Care Liquid Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05975827

Long2024-DFU-Sterile dressing

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Sterile Wound Care Liquid Dressing

Experimental group

Treatment:

Device: Sterile Wound Care Liquid Dressing

Control

No Intervention group