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

Diabetic Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05975827
• Other study ID #: Long2024-DFU-Sterile dressing
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Peking University Third Hospital
• Contact: Long Zhang, MD
• Phone: +86 010-82266699
• Email: longzh2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Ulcers
• Necrosis
• Ulcer

Intervention

Device:
• Sterile Wound Care Liquid Dressing
Sterile wound care liquid dressing is used in the wound treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-week reduction rate of wound area		2-week
Secondary	2-week wound healing rate		2-week