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

NCT05975827 | Not Yet Recruiting DMC

• 1 other identifier: Long2024-DFU-Sterile dressing
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Ulcers; Diabetic Ulcers in Necrosis Stable Stage

Keywords

Diabetic Ulcers

Outcome Measures

Primary Outcomes (1)

• 2-week reduction rate of wound area

  2-week

Secondary Outcomes (1)

• 2-week wound healing rate

  2-week

Study Arms (2)

Sterile Wound Care Liquid Dressing

EXPERIMENTAL

Device: Sterile Wound Care Liquid Dressing

Control

NO INTERVENTION

Interventions

Sterile Wound Care Liquid Dressing DEVICE

Sterile wound care liquid dressing is used in the wound treatment

Sterile Wound Care Liquid Dressing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected.
• Poor glycemic control; fasting blood glucose \>15mmol/L; glycosylated hemoglobin \>12%.
• Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
• Serum albumin \<20g/L; hemoglobin \<60g/L; platelets \<50×10\^9/L
• Advanced malignant tumor patients
• Autoimmune disease activity period
• History of allergy to aseptic wound care liquid dressing
• Patient unable to cooperate or has mental disorders
• Pregnant and lactating women
• Eye injuries and natural cavities such as ear canal, nasal cavity or abdominal cavity
• Skin tumors
• Active skin diseases
• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Central Study Contacts

Long Zhang, MD

CONTACT

+86 010-82266699; longzh2000@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04