Diabetic FootNCT05577104
Wound Bed Preparation for Diabetic Foot Ulcers
A study testing Negative pressure wound therapy (NPWT) and conventional moist dressings in people with Diabetic Foot, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Negative pressure wound therapy (NPWT) and conventional moist dressings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210029
Yin Wu, phD, 18305155832, medwuyin@163.com
Chao Hao, MD, 15905166117, haochao@163.com
About this study
Official title: The Comparison of Negative Pressure Wound Therapy (NPWT) and Conventional Moist Dressings in the Wound Bed Preparation for Diabetic Foot Ulcers
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.
Read the 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.
- Conditions
- Diabetic Foot
- Being tested
- Negative pressure wound therapy (NPWT), conventional moist dressings
- Keywords
- diabetic foot ulcers, negative pressure wound therapy, wound blood perfusion, neutrophil extracellular traps
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapy (NPWT)Procedure or surgery
For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).
conventional moist dressingsProcedure or surgery
For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).
| Study group | Role | What they receive |
|---|---|---|
| the NPWT group | Experimental | For patients in the NPWT group, the wound bed preparation was facilitated by VAC device. Receives: Procedure: Negative pressure wound therapy (NPWT) |
| the control group | Active comparator | For patients in the control group, the wound bed preparation was facilitated by alginates dressing change method. Receives: Procedure: conventional moist dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to STSG surgery
the duration from first surgical debridement to STSG surgery
Measured: 3 months post debridement
Secondary outcomes (2)
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.
Measured: Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
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.
Measured: Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 May 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients with diabetic foot ulcers (DFUs)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YinWu, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Yin Wu, phD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577104
- Sponsor's protocol ID
- KY20220825-08
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) are to be shared with other researchers.
Publications
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.
PubMed 30246926
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Negative Pressure Wound Therapy (NPWT) and Conventional Moist Dressings in the Wound Bed Preparation for Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05577104
- Acronym / sponsor ID
- KY20220825-08
- Conditions
- Diabetic Foot
- Keywords
- diabetic foot ulcers, negative pressure wound therapy, wound blood perfusion, neutrophil extracellular traps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients with diabetic foot ulcers (DFUs)
| Arm | Type | Receives |
|---|---|---|
| the NPWT group | Experimental | Procedure: Negative pressure wound therapy (NPWT)For patients in the NPWT group, the wound bed preparation was facilitated by VAC device. |
| the control group | Active comparator | Procedure: conventional moist dressingsFor patients in the control group, the wound bed preparation was facilitated by alginates dressing change method. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure wound therapy (NPWT)For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC). | Procedure or surgery | the NPWT group |
| conventional moist dressingsFor patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ). | Procedure or surgery | the control group |
Primary outcome
the time to STSG surgery
Time frame: 3 months post debridement
the duration from first surgical debridement to STSG surgery
2 secondary outcomes
the wound blood perfusion
Time frame: Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
the wound neutrophil extracellular traps (NETs) formation
Time frame: Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Results publication: PubMed 30246926Tettelbach 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.
- PubmedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) are to be shared with other researchers.
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EDX110 Randomized Control Trial for Treatment of DFUs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin Wu, phD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy (NPWT) and conventional moist dressings in people with Diabetic Foot, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin Wu, phD (18305155832, medwuyin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to STSG surgery (time frame: 3 months post debridement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05577104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.