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Not yet recruitingNCT05975827Updated Apr 29, 2024

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

An interventional study of Sterile Wound Care Liquid Dressing in Diabetic Ulcers and Diabetic Ulcers in Necrosis Stable Stage, sponsored by Peking University Third Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Ulcers
  • Diabetic Ulcers in Necrosis Stable Stage

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Keywords

  • Diabetic Ulcers
03

In context

Necrosis

90 studies on the registry are indexed under Necrosis; 23 are open to participants now.

This study's planned enrollment of 28 is below the median of 50 across 53 interventional studies indexed under Necrosis.

Browse Necrosis studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 >12%.
  3. Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
  4. Serum albumin \<20g/L; hemoglobin \<60g/L; \<50×10\^9/L
  5. Advanced malignant tumor patients
  6. 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Sterile Wound Care Liquid Dressing

    Device: Sterile Wound Care Liquid Dressing

  • No intervention
    Control

Interventions

  • DeviceSterile Wound Care Liquid Dressing

    Sterile wound care liquid dressing is used in the wound treatment

06

What researchers measure

Primary outcomes

  1. 2-week reduction rate of wound area

    Time frame: 2-week

Secondary outcomes

  1. 2-week wound healing rate

    Time frame: 2-week

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05975827
Responsible party
Long Zhang (Professor, Peking University Third Hospital) — Principal investigator
First posted
Aug 4, 2023
Start date
May 1, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Apr 29, 2024

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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