Clinical trial NCT05041244: Negative Pressure Wound Therapy in Diabetic Wounds
Official title: Identification of Biomarkers, Prognostic Indicators and Development of Novel Interface Devices for the Clinical Use of Topical Negative Pressure in Diabetic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Keywords: Negative pressure wound therapy, diabetic foot ulcer
Lead sponsor: University of Mauritius
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Wellness, Mauritius
name: Higher Education Commission, Mauritius
name: Acelity
First posted: 2021-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Superiority, multi-centre randomised parallel groups
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 - 75 years
4. In good general health as evidenced by medical history or diagnosed with diabetes mellitus or exhibiting signs of diabetic foot ulcers
5. Patients suffering from diabetic foot ulcer last more than 3 weeks
6. Patients with diabetes and presence of a foot wound for more than 3 weeks

Exclusion Criteria:

1. Patients under \<18 years or above 75 years
2. Patients unable to provide consent
3. Patients suffering from chronic kidney disease or liver impairment or other chronic conditions
4. Patients on anticoagulants
5. Patients with non diabetic ulcers
6. Patients with severe peripheral vascular disease
7. Patients having contra-indication to negative pressure wound therapy

Primary outcomes:
measure: Wound closure
timeFrame: 3 weeks
Secondary outcomes:
measure: Biomarkers
timeFrame: 3 weeks
measure: complete wound closure
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Le Réduit
country: Mauritius
facility: University of Mauritius
state: Moka
Study officials:
affiliation: University of Mauritius
name: Abha Jodheea-Jutton, MBBS MRCGP
role: PRINCIPAL_INVESTIGATOR
References: