Negative Pressure Wound Therapy in Diabetic Wounds
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional

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.
    

Intervention name(s): Negative pressure wound therapy delivered through VAC; Standard of care
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): Hydrogel, foams, pad and other dressings
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Superiority, multi-centre randomised parallel groups
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Negative pressure wound therapy, diabetic foot ulcer