Identification of Biomarkers, Prognostic Indicators and Development of Novel Interface Devices for the Clinical Use of Topical Negative Pressure in Diabetic Wounds
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Mauritius
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Wound closure
Study Overview
Brief 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. 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Wound closure
Time Frame: 3 weeks
Any wound closure or % reduction in size
Secondary Outcomes
- complete wound closure(1 year)
- Biomarkers(3 weeks)
- Adverse events(1 year)
Investigators
Archana BHAW LUXIMON
Professor
University of Mauritius