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

April 26, 2024 updated by: Long Zhang, Peking University Third Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-week reduction rate of wound area
Time Frame: 2-week
2-week

Secondary Outcome Measures

Outcome Measure
Time Frame
2-week wound healing rate
Time Frame: 2-week
2-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Long2024-DFU-Sterile dressing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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