Wound Bed Preparation for Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Procedure: Negative pressure wound therapy (NPWT)
* Procedure: conventional moist dressings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients with diabetic foot ulcers (DFUs)
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to STSG surgery | 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 | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot ulcers, negative pressure wound therapy, wound blood perfusion, neutrophil extracellular traps