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

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ClinicalTrials.gov Identifier: NCT05975827
Recruitment Status : Not yet recruiting
First Posted : August 4, 2023
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
Long Zhang, Peking University Third Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetic Ulcers Diabetic Ulcers in Necrosis Stable Stage Device: Sterile Wound Care Liquid Dressing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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 Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 2-week reduction rate of wound area [ Time Frame: 2-week ]

Secondary Outcome Measures :
  1. 2-week wound healing rate [ Time Frame: 2-week ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975827


Contacts
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Contact: Long Zhang, MD +86 010-82266699 longzh2000@163.com

Sponsors and Collaborators
Peking University Third Hospital
More Information
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Responsible Party: Long Zhang, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT05975827    
Other Study ID Numbers: Long2024-DFU-Sterile dressing
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Long Zhang, Peking University Third Hospital:
Diabetic Ulcers
Additional relevant MeSH terms:
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Ulcer
Necrosis
Pathologic Processes