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Wound Bed Preparation for Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Negative pressure wound therapy (NPWT)

conventional moist dressings

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring diabetic foot ulcers, negative pressure wound therapy, wound blood perfusion, neutrophil extracellular traps

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with DFUs aged 20-80 years.
Wagner grade 2 to 3.
Chronic DFUs wounds (duration of disease ≥ 2 weeks).
Ankle brachial ratio (ABI) 0.5～0.9, wound area 8~20 cm2.

Exclusion Criteria:

Patients who were unable to complete the follow-up were not included,
Pregnant or nursing mothers were not included.
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.
Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.
Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.

Sites / Locations

Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the NPWT group

the control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

the time to STSG surgery

the duration from first surgical debridement to STSG surgery

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05577104

First Posted

October 10, 2022

Last Updated

October 10, 2022

Sponsor

Nanjing First Hospital, Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05577104

Brief Title

Wound Bed Preparation for Diabetic Foot Ulcers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot

Keywords

diabetic foot ulcers, negative pressure wound therapy, wound blood perfusion, neutrophil extracellular traps

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The patients with diabetic foot ulcers (DFUs)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the NPWT group

Arm Type

Experimental

Arm Description

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

Arm Title

the control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Negative pressure wound therapy (NPWT)

Intervention Description

For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).

Intervention Type

Procedure

Intervention Name(s)

conventional moist dressings

Intervention Description

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

Primary Outcome Measure Information:

Title

the time to STSG surgery

Description

the duration from first surgical debridement to STSG surgery

Time Frame

3 months post debridement

Secondary Outcome Measure Information:

Title

the wound blood perfusion

Description

The blood perfusion of the DFUs wounds were evaluated by the laser speckle contrast imaging (LSCI) instrument. The higher value means a better outcome.

Time Frame

Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).

Title

the wound neutrophil extracellular traps (NETs) formation

Description

Time Frame

Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with DFUs aged 20-80 years. Wagner grade 2 to 3. Chronic DFUs wounds (duration of disease ≥ 2 weeks). Ankle brachial ratio (ABI) 0.5～0.9, wound area 8~20 cm2. Exclusion Criteria: Patients who were unable to complete the follow-up were not included, Pregnant or nursing mothers were not included. 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. Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yin Wu, phD

Phone

18305155832

medwuyin@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chao Hao, MD

Phone

025-52271006

cathywuyin@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yin Wu, phD

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanjing First Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yin Wu, phD

Phone

18305155832

medwuyin@163.com

First Name & Middle Initial & Last Name & Degree

Chao Hao, MD

Phone

15905166117

haochao@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) are to be shared with other researchers.

IPD Sharing Time Frame

The data will become available on December,2023. The data will become available for 1 year.

IPD Sharing Access Criteria

everyone

IPD Sharing URL

http://www.stats.gov.cn/tjsj/

Citations:

PubMed Identifier

30246926

Citation

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 Wound J. 2019 Feb;16(1):122-130. doi: 10.1111/iwj.13001. Epub 2018 Sep 24.

Results Reference

result

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/30246926/

Description

Pubmed

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Wound Bed Preparation for Diabetic Foot Ulcers

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