Wound Bed Preparation for Diabetic Foot Ulcers

October 10, 2022 updated by: YinWu, Nanjing First Hospital, Nanjing Medical University

The Comparison of Negative Pressure Wound Therapy (NPWT) and Conventional Moist Dressings in the Wound Bed Preparation for Diabetic Foot Ulcers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The diabetic foot ulcers (DFUs) are major complications of patients with diabetes mellitus. Split thickness skin graft (STSG) surgery is a cost-effective method for the rapid healing of DFUs. The aim of this study was to compare the efficacy of negative pressure wound therapy (NPWT) using vacuum-assisted closure (VAC) device versus conventional moist dressings (alginates) on the wound bed preparation prior to STSG surgery for patients with chronic DFUs.

This ia a prospective, randomized controlled trial. All the patients were randomly divided into two groups: the NPWT group or the control group. Once the DFUs wound was filled with healthy granulation tissues, STSG surgery was performed. The primary endpoint included the time to STSG surgery (the duration from first surgical debridement to STSG surgery). The secondary endpoints included the survival rates of skin graft, the wound blood perfusion, the wound neutrophil extracellular traps (NETs) formation, and polarization of M1 or M2 macrophages in the DFUs wounds of the two groups.

Study Type

Interventional

Enrollment (Anticipated)

40

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

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Nanjing First Hospital
        • Contact:
        • 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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with DFUs aged 20-80 years.
  2. Wagner grade 2 to 3.
  3. Chronic DFUs wounds (duration of disease ≥ 2 weeks).
  4. Ankle brachial ratio (ABI) 0.5～0.9, wound area 8~20 cm2.

Exclusion Criteria:

  1. Patients who were unable to complete the follow-up were not included,
  2. Pregnant or nursing mothers were not included.
  3. 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.
  4. Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.
  5. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the NPWT group
For patients in the NPWT group, the wound bed preparation was facilitated by VAC device.
Procedure: Negative pressure wound therapy (NPWT)
For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).
Active Comparator: the control group
For patients in the control group, the wound bed preparation was facilitated by alginates dressing change method.
Procedure: conventional moist dressings
For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time to STSG surgery
Time Frame: 3 months post debridement
the duration from first surgical debridement to STSG surgery
3 months post debridement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the wound blood perfusion
Time Frame: Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
The blood perfusion of the DFUs wounds were evaluated by the laser speckle contrast imaging (LSCI) instrument. The higher value means a better outcome.
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
Time Frame: Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
The wound granulation tissues (1 mL) were collected from the DFU wound of patients. The wound granulation tissues were stained for NETs by immunofluorescence. Samples were stained with anti-human neutrophil elastase antibody and anti-human myeloperoxidase antibody. Visualization was performed with confocal microscopy. The higher number of NETs means a worse outcome.
Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Yin Wu, phD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

May 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 10, 2022

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20220825-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) are to be shared with other researchers.

IPD Sharing Time Frame

The data will become available on December,2023. The data will become available for 1 year.

IPD Sharing Access Criteria

everyone

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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