Wound Bed Preparation for Diabetic Foot Ulcers
The Comparison of Negative Pressure Wound Therapy (NPWT) and Conventional Moist Dressings in the Wound Bed Preparation for Diabetic Foot Ulcers
1 other identifier
interventional
40
1 country
1
Brief Summary
The study objective was to compare the efficacy of NPWT versus alginates dressings on the wound bed preparation prior to STSG surgery, as well as investigating the underlying mechanisms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2022
CompletedOctober 13, 2022
October 1, 2022
7 months
October 10, 2022
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the time to STSG surgery
the duration from first surgical debridement to STSG surgery
3 months post debridement
Secondary Outcomes (2)
the wound blood perfusion
Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
the wound neutrophil extracellular traps (NETs) formation
Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
Study Arms (2)
the NPWT group
EXPERIMENTALFor patients in the NPWT group, the wound bed preparation was facilitated by VAC device.
the control group
ACTIVE COMPARATORFor patients in the control group, the wound bed preparation was facilitated by alginates dressing change method.
Interventions
For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).
For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).
Eligibility Criteria
You may qualify if:
- Patients with DFUs aged 20-80 years.
- Wagner grade 2 to 3.
- Chronic DFUs wounds (duration of disease ≥ 2 weeks).
- Ankle brachial ratio (ABI) 0.5～0.9, wound area 8\~20 cm2.
You may not qualify if:
- Patients who were unable to complete the follow-up were not included,
- Pregnant or nursing mothers were not included.
- Patients with foot ulcers other than diabetes, peripheral vascular disease, organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
- Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.
- Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing First Hospital
Nanjing, Jiangsu, 210029, China
Related Publications (1)
Tettelbach W, Cazzell S, Sigal F, Caporusso JM, Agnew PS, Hanft J, Dove C. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Int Wound J. 2019 Feb;16(1):122-130. doi: 10.1111/iwj.13001. Epub 2018 Sep 24.
PMID: 30246926RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yin Wu, phD
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 13, 2022
Study Start
May 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 10, 2022
Last Updated
October 13, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The data will become available on December,2023. The data will become available for 1 year.
- Access Criteria
- everyone
The Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) are to be shared with other researchers.