Diabetic Foot
Conditions
Keywords
diabetic foot ulcers, negative pressure wound therapy, wound blood perfusion, neutrophil extracellular traps
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.
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.
Interventions
For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).
PROCEDUREconventional moist dressings
For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The patients with diabetic foot ulcers (DFUs)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the time to STSG surgery | 3 months post debridement | the duration from first surgical debridement to STSG surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the wound blood perfusion | 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. |
| 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). | 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. |
Countries
China
Contacts
Primary ContactYin Wu, phD
Backup ContactChao Hao, MD
Outcome results
None listed