Wound Bed Preparation for Diabetic Foot Ulcers

Nanjing Medical University

Status: Enrolling

Conditions: Diabetic Foot

Treatments: Procedure: Negative pressure wound therapy (NPWT); Procedure: conventional moist dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT05577104

KY20220825-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

the NPWT group

Experimental group

Description:

For patients in the NPWT group, the wound bed preparation was facilitated by VAC device.

Treatment:

Procedure: Negative pressure wound therapy (NPWT)

the control group

Active Comparator group

Description:

For patients in the control group, the wound bed preparation was facilitated by alginates dressing change method.

Treatment:

Procedure: conventional moist dressings