Wound Bed Preparation for Diabetic Foot Ulcers

Not Applicable

Recruiting

• Conditions: Diabetic Foot
• Interventions: Procedure: Negative pressure wound therapy (NPWT); Procedure: conventional moist dressings

• Registration Number: NCT05577104
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Last Update Submitted: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the NPWT group	Negative pressure wound therapy (NPWT)	For patients in the NPWT group, the wound bed preparation was facilitated by VAC device.
the control group	conventional moist dressings	For patients in the control group, the wound bed preparation was facilitated by alginates dressing change method.

Primary Outcome Measures

Name	Time	Method
the time to STSG surgery	3 months post debridement	the duration from first surgical debridement to STSG surgery

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China