Wound Bed Preparation for Diabetic Foot Ulcers

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577104
• Other study ID #: KY20220825-08
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: October 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Yin Wu, phD
• Phone: 18305155832
• Email: medwuyin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 10, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

Procedure:
• Negative pressure wound therapy (NPWT)
For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).
• conventional moist dressings
For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Tettelbach W, Cazzell S, Sigal F, Caporusso JM, Agnew PS, Hanft J, Dove C. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Int Wou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to STSG surgery	the duration from first surgical debridement to STSG surgery	3 months post debridement
Secondary	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).
Secondary	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).

External Links

•   Pubmed