Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment
Condition: Wounds and Injuries; Negative Pressure Therapy; Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Wounds and Injuries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MedCu wound dressings with copper oxide (COD)
Intervention type(s): Device
Intervention description(s): Patients whose foot wound is indicated for VAC treatment will be randomized to either treatment arm after signing informed consent.
Other intervention name(s): Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment
Intervention MeSH terms: Copper
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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").
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wound dressings; copper oxide; diabetic ulcers; Negative pressure wound therapy