Wound Bed Preparation for Diabetic Foot Ulcers

Last updated: October 10, 2022
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT05577104
KY20220825-08
  • Ages 20-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, organdysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairmentor intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosingspondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissuesdisease or systemic vasculitis) were not included.
  4. Patients who received growth factors or hyperbaric oxygen therapies for the DFUswounds within one month were not included.
  5. Patients who had medications (such as corticosteroids, immunosuppressive agents orchemotherapy) within six months were not included.

Study Design

Total Participants: 40
Study Start date:
May 01, 2022
Estimated Completion Date:
December 10, 2022

Study 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.

Connect with a study center

  • Nanjing First Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

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