Diabetic FootNCT05041244
Negative Pressure Wound Therapy in Diabetic Wounds
A study testing Negative pressure wound therapy delivered through VAC in people with Diabetic Foot, run by University of Mauritius at 1 site in Mauritius.
Trial summary
Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Negative pressure wound therapy delivered through VAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMauritius
- Study dates
- 1 May 2019to 1 Jul 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 - 75 years
- In good general health as evidenced by medical history or diagnosed with diabetes mellitus or exhibiting signs of diabetic foot ulcers
- Patients suffering from diabetic foot ulcer last more than 3 weeks
- Patients with diabetes and presence of a foot wound for more than 3 weeks
Who cannot join
- Patients under <18 years or above 75 years
- Patients unable to provide consent
- Patients suffering from chronic kidney disease or liver impairment or other chronic conditions
- Patients on anticoagulants
- Patients with non diabetic ulcers
- Patients with severe peripheral vascular disease
- Patients having contra-indication to negative pressure wound therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Biomarkers, Prognostic Indicators and Development of Novel Interface Devices for the Clinical Use of Topical Negative Pressure in Diabetic Wounds
Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment. Patient with DFU will be selected based on an eligible criteria and randomly assigned to intervention group or control group.
Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis A randomised controlled study is being proposed, where up to 100 participants will be recruited.
The wounds of participants in the intervention arm will be managed with 3 weeks of TNPW.
Read the detailed description
Study Description: Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment
Objectives:
Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis
Endpoints:
Primary Endpoint:
Incidence of complete wound closure at 7, 14 and 21 days Time for complete wound closure Side and depth of diabetic ulcer at 7, 14, 21 days Extent of granulation tissue (Epithelialisation) (7- 21 days)
Secondary Endpoints: Hospital stay, readmission, rate of amputation and rate of infections and adverse events Number of dressing changes
Study Population: 50 patients in each arm (interventional and control) Chronic diabetic ulcers, Wagner's 2-3 Male and female Diabetes Mellitus without renal and liver impairment Age 18- 74 years Stable patients with Diabetic foot ulcer A G Jeetoo Hospital, Port-Louis and Souillac District Hospital
Phase: 2 Description of Sites/Facilities Enrolling Participants: The study will take place at the above mentioned units Approval has been received by the Regional Health Director and Consultant in Charge and the Ministry of Health and Wellness for A G Jeetoo Hospital and Souillac District Hospital.
Patients will be recruited from the Diabetes Clinic or the General Surgery Department.
Patients with chronic diabetic ulcer fulfilling the eligibility criteria Description of Study Intervention: Patients will be randomized to Negative Pressure Wound Therapy (TNPW) arm and conventional treatment arm offered at the above named hospitals. TNPW devices will be used in patients in the intervention arm for 3 weeks.
TNPW is described as a medical procedure which involves application of a dressing to the wound. The dressing is attached to a vacuum device that provides sub-atmospheric pressures which help in the removal of exudates to promote the healing process. Dressings will be changed weekly.
Study Duration: 12 months Participant Duration: Each participant will be followed weekly during the procedure then 3 monthly to assess wound healing and enquire about need for further treatment including admissions and long term adverse effects.
- Conditions
- Diabetic Foot
- Being tested
- Negative pressure wound therapy delivered through VAC, Standard of care
- Keywords
- Negative pressure wound therapy, diabetic foot ulcer
- 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 delivered through VACDevice
Initial cycle: Continuous first 48 hours Subsequent cycle: Consider intermittent DPC (5 min ON/2 mins OFF) for rest of the therapy Target Target Pressure: 50-175mmHg, to be titrated for more drainage Dressing change interval: every week; need for more frequent dressing need to be evaluated. More frequent change of adaptic can be considered. (Adaptic is a layer of thin dressing that will be in direct contact with the wound to reduce the risk of maceration and adherence to the dressing)
Standard of careDevice
Also called Hydrogel, foams, pad and other dressings
Participants in the control arm will have their dressings changed as per the current standard of care.
Effective management of DFU will depend on accurate diagnosis and assessment and appropriate debridement of non-viable tissues in patients from both arms Patients will be advised to continue off loading and any evidence of early infection should be promptly treated.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | NPWT will be delivered through devices (ActiVac and InfoVac) according to FDA protocol in conjunction with the polyurethane foams. Dressing changed will be on a weekly basis. Receives: Device: Negative pressure wound therapy delivered through VAC |
| Control | Other | Standard of care Participants will be given the standard care provided in specialist foot care clinics or in-patients. Receives: Device: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure
Any wound closure or % reduction in size
Measured: 3 weeks
Secondary outcomes (3)
Biomarkers
The amount of granulation will be determined macroscopically and microscopically through histology. Biomarkers such IL6 TNF and CD31/33 will be analysed from tissue specimens
Measured: 3 weeks
complete wound closure
the incidence of complete closure will be determined and compared between the intervention group and the control group
Measured: 1 year
Adverse events
Adverse events will include physical and psychological distress as well as infections and admissions to hospitals or recurrence of ulcer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 May 2019
- Primary completion1 Mar 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- 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
- Superiority, multi-centre randomised parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mauritius
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Wellness, Mauritius, Higher Education Commission, Mauritius, Acelity
- Responsible party
- Principal investigator, Archana BHAW LUXIMON, University of Mauritius
- Investigators
- Abha Jodheea-Jutton, MBBS MRCGP, Principal investigator, University of Mauritius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041244
- Sponsor's protocol ID
- 50/14.2.2018
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD has been stored in digital format in anonymised way and might be shared with other researchers on request. The request will be considered by the members of the team.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers, Prognostic Indicators and Development of Novel Interface Devices for the Clinical Use of Topical Negative Pressure in Diabetic Wounds
- ClinicalTrials.gov ID
- NCT05041244
- Acronym / sponsor ID
- 50/14.2.2018
- Conditions
- Diabetic Foot
- Keywords
- Negative pressure wound therapy, diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MauritiusUniversity, hospital or other
- Collaborators
- Ministry of Health and Wellness, Mauritius, Higher Education Commission, Mauritius, Acelity
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 13 Sep 2021 (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.
Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment. Patient with DFU will be selected based on an eligible criteria and randomly assigned to intervention group or control group.
Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis A randomised controlled study is being proposed, where up to 100 participants will be recruited.
The wounds of participants in the intervention arm will be managed with 3 weeks of TNPW.
Detailed description
Study Description: Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment
Objectives:
Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis
Endpoints:
Primary Endpoint:
Incidence of complete wound closure at 7, 14 and 21 days Time for complete wound closure Side and depth of diabetic ulcer at 7, 14, 21 days Extent of granulation tissue (Epithelialisation) (7- 21 days)
Secondary Endpoints: Hospital stay, readmission, rate of amputation and rate of infections and adverse events Number of dressing changes
Study Population: 50 patients in each arm (interventional and control) Chronic diabetic ulcers, Wagner's 2-3 Male and female Diabetes Mellitus without renal and liver impairment Age 18- 74 years Stable patients with Diabetic foot ulcer A G Jeetoo Hospital, Port-Louis and Souillac District Hospital
Phase: 2 Description of Sites/Facilities Enrolling Participants: The study will take place at the above mentioned units Approval has been received by the Regional Health Director and Consultant in Charge and the Ministry of Health and Wellness for A G Jeetoo Hospital and Souillac District Hospital.
Patients will be recruited from the Diabetes Clinic or the General Surgery Department.
Patients with chronic diabetic ulcer fulfilling the eligibility criteria Description of Study Intervention: Patients will be randomized to Negative Pressure Wound Therapy (TNPW) arm and conventional treatment arm offered at the above named hospitals. TNPW devices will be used in patients in the intervention arm for 3 weeks.
TNPW is described as a medical procedure which involves application of a dressing to the wound. The dressing is attached to a vacuum device that provides sub-atmospheric pressures which help in the removal of exudates to promote the healing process. Dressings will be changed weekly.
Study Duration: 12 months Participant Duration: Each participant will be followed weekly during the procedure then 3 monthly to assess wound healing and enquire about need for further treatment including admissions and long term adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Superiority, multi-centre randomised parallel groups
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Negative pressure wound therapy delivered through VACNPWT will be delivered through devices (ActiVac and InfoVac) according to FDA protocol in conjunction with the polyurethane foams. Dressing changed will be on a weekly basis. |
| Control | Other | Device: Standard of careStandard of care Participants will be given the standard care provided in specialist foot care clinics or in-patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 - 75 years
- In good general health as evidenced by medical history or diagnosed with diabetes mellitus or exhibiting signs of diabetic foot ulcers
- Patients suffering from diabetic foot ulcer last more than 3 weeks
Key exclusion criteria (7 listed)
- Patients under <18 years or above 75 years
- Patients unable to provide consent
- Patients suffering from chronic kidney disease or liver impairment or other chronic conditions
- Patients on anticoagulants
- Patients with non diabetic ulcers
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 delivered through VACInitial cycle: Continuous first 48 hours Subsequent cycle: Consider intermittent DPC (5 min ON/2 mins OFF) for rest of the therapy Target Target Pressure: 50-175mmHg, to be titrated for more drainage Dressing change interval: every week; need for more frequent dressing need to be evaluated. More frequent change of adaptic can be considered. (Adaptic is a layer of thin dressing that will be in direct contact with the wound to reduce the risk of maceration and adherence to the dressing) | Device | Interventional arm |
| Standard of careAlso: Hydrogel, foams, pad and other dressingsParticipants in the control arm will have their dressings changed as per the current standard of care. Effective management of DFU will depend on accurate diagnosis and assessment and appropriate debridement of non-viable tissues in patients from both arms Patients will be advised to continue off loading and any evidence of early infection should be promptly treated. | Device | Control |
Primary outcome
Wound closure
Time frame: 3 weeks
Any wound closure or % reduction in size
3 secondary outcomes
Biomarkers
Time frame: 3 weeks
complete wound closure
Time frame: 1 year
Adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No. All IPD has been stored in digital format in anonymised way and might be shared with other researchers on request. The request will be considered by the members of the team.
Related trials for Diabetic Foot
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EDX110 Randomized Control Trial for Treatment of DFUs
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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
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Better Care Closer to Home: Enhancing Primary and Community Care
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Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
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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.
Abha Jodheea-Jutton, MBBS MRCGP principal investigator
University of Mauritius
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 delivered through VAC in people with Diabetic Foot, run by University of Mauritius at 1 site in Mauritius.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 13 Sep 2021. 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 Mauritius. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2021.