Safety and Efficacy Study of MedCu Wound Dressings
Condition: Wounds and Injuries; Diabetes Complications
MeSH terms: Diabetes Complications; Wounds and Injuries
Study type: Interventional

Summary: 
      The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1
      month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken
      for analysis of blood count, liver and kidney functions from potential appropriate diabetic
      patients with chronic wounds in their foot. Stable chronic diabetic patients, whose wounds
      were not infected and the wound size increased or did not decreased by more than 25% per week
      or 35% by SOC treatment during the Screening Phase, and who will meet all other study
      inclusion criteria, were enrolled and start the 4 weeks Treatment Phase. The wounds were then
      treated by applying the Copper Oxide containing Dressings (COD) that were changed twice a
      week. In the two weeks post-treatment period, the patient received standard of care (SOC)
      dressing. In that time period, the patient were seen once after two weeks. The Primary
      outcome was the evaluation of the safety of the COD and the secondary outcomes were the
      evaluation of the wound size change of the foot wounds when using COD. Measures that were
      assessed included

        1. Percent change in wound size during the Treatment Phase,

        2. Rate of increase in extent and quality (color) of granulation tissue,

        3. Infectious episodes during the Treatment Phase.
    

Detailed description: 
      The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1
      month); and Follow-up Phase (two weeks). During the Screening Phase, blood samples were taken
      for analysis of blood count, liver and kidney functions from potential appropriate diabetic
      patients with chronic wounds in their foot. Stable chronic diabetic patients, whose wounds
      were not infected and the wound size increased or did not decreased by more than 25% per week
      or 35% by SOC treatment during the Screening Phase, and who will meet all other study
      inclusion criteria, were enrolled and start the 4 weeks Treatment Phase.

      During the Treatment Phase, the index wounds were evaluated, undergone bed side debridement
      if necessary, and photographed. Tissue Analytics software was used to assess wound size and
      volume. The wounds were washed by normal saline or a previously used solution (but no new
      disinfectant or any antibacterial preparation), and then the COD was applied on the wound.
      The COD was applied on the wounds for the duration of the Treatment Phase and changed twice a
      week, once in the clinic and once at home. At every clinic visit the following assessments
      were performed: wound assessment, including size determination, depth, clinical impression of
      infection (swelling, erythema, discharge quantity and quality, granulation, fibrin and
      necrotic tissue, odor, pain, and tenderness); antibiotics and vital signs as necessary. After
      ~ 1 month of test wound dressings use, a blood sample was taken for blood count, liver and
      kidney functions. If needed, the patients' wounds were treated using the hospital SOC in the
      follow up period. The Primary outcome was the evaluation of the safety of the COD and the
      secondary outcomes were the evaluation of the wound size change of the foot wounds when using
      COD. Measures that were assessed included

        1. Percent change in wound size during the Treatment Phase,

        2. Rate of increase in extent and quality (color) of granulation tissue,

        3. Infectious episodes during the Treatment Phase.
    

Intervention name(s): Application of Wound Dressings with Copper Oxide
Intervention type(s): Device
Intervention description(s): Application of Wound Dressings with Copper Oxide on chronic foot wounds in diabetic patients
Intervention MeSH terms: Copper
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wound dressings; copper oxide; diabetic ulcers