Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05975827
• Collaborator: (none)
• Enrollment: 600
• Arms: 2
• Anticipated Duration (Months): 14

Study Details

Study Description

Brief Summary

The goal of this randomized control trial is to test the efficacy and safety of the sterile wound care liquid dressing in patients with diabetes foot ulcer in different stages. The main question it aims to answer are:

• Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of diabetes foot ulcer in infection progressive stage？

• Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of diabetes foot ulcer in necrosis stable stage？

• Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage？ Participants will be assigned with a 1:1 ratio into intervention group and control group.

Participants of intervention group will receive sterile wound care liquid dressing in addition with clinical optimal treatment plan. Participants of control group will only receive clinical optimal treatment plan.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Foot Ulcer	Device: Sterile Wound Care Liquid Dressing	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sterile Wound Care Liquid Dressing	Device: Sterile Wound Care Liquid Dressing; Sterile wound care liquid dressing is used in the wound treatment
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. 2-week reduction rate of wound area [2-week]

Secondary Outcome Measures

1. 2-week wound healing rate [2-week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The patient is aged 18-80 years old;

2. Diagnose diabetes according to WHO standards;

3. Diagnose diabetes ulcer;

4. Confirmed as one of the stages of infection progression, necrosis stable, or granulation growth;

5. The Pregnancy test of female patients with Fertility must be negative;

6. Non eye damage to the wound surface and natural cavities such as the ear cavity, nasal cavity, and abdominal cavity;

7. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

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

2. Uncontrolled blood glucose, Glucose test#Fasting blood sugar>15mmol/L, Glycated hemoglobin>12%;

3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;,4. Serum albumin < 20g/L; Hemoglobin < 60g/L; Platelets<50 × 10^9/L;

4. Patients with advanced malignant tumors; 6. Active period of autoimmune diseases; 7. Allergic history of sterile wound care liquid dressings; 8. The patient is unable to cooperate or has mental disorders; 9. Pregnant and lactating women;,10. Eye damage and natural cavities such as the ear, nose, and abdominal cavity; 11. Skin tumors; 12. Active skin diseases; 13. According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Long Zhang, Professor, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05975827
• Other Study ID Numbers: Long2023-DFU-Sterile dressing
• First Posted: Aug 4, 2023
• Last Update Posted: Aug 4, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Long Zhang, Professor, Peking University Third Hospital: Diabetes foot ulcer
• Additional relevant MeSH terms: Foot Ulcer; Diabetes Mellitus; Ulcer

Study Results

No Results Posted as of Aug 4, 2023