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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05975827
Other study ID # Long2024-DFU-Sterile dressing
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Withdrawn NCT02361437 - Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers N/A