An interventional study of Negative pressure wound therapy delivered through VAC and Standard of care in Diabetic Foot, sponsored by University of Mauritius. Completed at 1 site in Mauritius. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by University of Mauritius · Not applicable, Interventional, and Treatment
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.
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →University of Mauritius is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Negative pressure wound therapy delivered through VAC
Standard of care Participants will be given the standard care provided in specialist foot care clinics or in-patients.
Device: Standard of care
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)
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.
Also known as: Hydrogel, foams, pad and other dressings
Wound closure
Any wound closure or % reduction in size
Time frame: 3 weeks
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
Time frame: 3 weeks
complete wound closure
the incidence of complete closure will be determined and compared between the intervention group and the control group
Time frame: 1 year
Adverse events
Adverse events will include physical and psychological distress as well as infections and admissions to hospitals or recurrence of ulcer
Time frame: 1 year
Plan to share: 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.
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in Mar 2021, 22 months.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 22 months is close to that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Mauritius