Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be treated with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). The study goals are to compare the efficacy, cost and convenience between MedCu Wound Dressings with Copper Oxide (COD) and Negative Pressure Wound Therapy of diabetic foot wounds.
Randomized multisite two arms study: one arm will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm"). The second arm with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). Prior to the commencement of the study the patients will be treated according to the caregiver routine and the wound and patient condition, e.g. surgical or bedside debridement, minor foot amputation and/or various wound dressings. Patients whose foot condition has improved and there is indication for VAC treatment will be randomized to either treatment arm after signing informed consent. The patients will be then treated for 2-8 weeks with the study treatment. Treatment termination - Treatment will be stopped due to the following reasons: 1. Treatment failure 1. Wound deterioration 2. Wound infection 3. Adverse events 2. Inability to continue the current treatment for any other reason unrelated to the treatment modality 3. Expected termination (two to eight weeks) - no indication to continue treatment arm or if sufficient granulation has been achieved and the patient is candidate for skin grafting 4. Wound closure The VAC treatment will be performed twice weekly, according to the routine practice (usually 75-150 mm Hg). The COD will be changed once a week or more often in highly exudating wounds. The patients will be monitored at least every two weeks in the clinic, but documentation of the wound condition will be obtained in every dressing change or VAC replacement. Follow-up Period - Patients will be monitored for two additional weekly or biweekly visits (total of 2-4 weeks). The Follow-up Period will be following treatment termination (including wound closure). In the follow-up period the patient will be treated according to the physician decision based on standard of care, available treatment and wound condition. Continue treatment with the same arm modality, for which the patient had been randomized is allowed and will be recorded. Change into the other arm treatment will be allowed but will be documented as a "Cross Over" and the reason for the cross over will be stated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Patients whose foot wound is indicated for VAC treatment will be randomized to either treatment arm after signing informed consent.
Rambam Health Care Campus
Haifa, Israel
Change in wound size
The size of the wound will be determined by using a 3D Wound Imaging System
Time frame: 4, 8 and 12 weeks of treatment
Physiological parameter - Change in granulation tissue
Percentage of granulation tissue will be determined based on the physicians evaluation and by Tissue Analytics Imaging system
Time frame: 4, 8 and 12 weeks of treatment
Physiological parameter - Percentage of wounds that will be closed during the study period
The percent of closed wounds per study group will be calculated and compared
Time frame: 12 weeks
Cost of treatment
The mean cost of treatment per patient in each of the two study groups will be calculated. It will include cost of the actual equipment (dressings versus VAC) and time of treatment by caregivers.
Time frame: 12 weeks
Convenience - patient perspective - Questionnaire
The patients will be asked to give an indication of their convenience perspective of the treatment by giving a grade between 1-10, being 1 "not convenient at all" and 10 "very convenient".
Time frame: 12 weeks
Convenience - caregiver perspective - Questionnaire
The caregivers will be asked to give an indication of their convenience perspective of the treatment by giving a grade between 1-10, being 1 "not convenient at all" and 10 "very convenient".
Time frame: 12 weeks
Pain - patients perspective - Questionnaire
The patients will be asked to give an indication of the pain they felt during treatment by giving a grade between 1-10, being 1 "felt no pain" and 10 "felt extreme pain".
Time frame: 12 weeks
Physiological parameter - Infectious episodes
The number of infectious episodes, which will include fever, antibiotic administration, and wound infection, during the trial will be recorded and compared between both study arms.
Time frame: 12 weeks
Physiological parameter - Number of treatment-related adverse events as assessed by CTCAE v4.0
The number of treatment-related adverse event episodes during the trial will be assessed in both study arms according to CTCAE v4.0
Time frame: 12 weeks
Physiological parameter - Change in necrotic tissue
Percentage of necrotic tissue will be determined based on the physicians evaluation and by Tissue Analytics Imaging system
Time frame: 4, 8 and 12 weeks of treatment
Physiological parameter - Change in fibrin tissue
Percentage of fibrin tissue will be determined based on the physicians evaluation and by Tissue Analytics Imaging system
Time frame: 4, 8 and 12 weeks of treatment
Physiological parameter - Average time to wound closure
The average time to close the wounds in each arm will be determined
Time frame: 12 weeks
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