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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05577104
Other study ID # KY20220825-08
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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).
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