Negative Pressure Wound Therapy as a Drug Delivery System
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      The investigators plan a randomized clinical trial of 150 patients with infected
      diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of
      negative pressure wound therapy with continuous irrigation and negative pressure wound
      therapy without irrigation.
    

Detailed description: 
      The investigators will enroll 150 patients from two centers: The University of Texas
      Southwestern University Hospital and Parkland Hospital. The investigators will screen and
      enroll patients with wounds in the inpatient setting. Patients will be randomized to receive
      traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average
      hospitalization for patients that receive NPWT is 13.3 days. Patients that do not have their
      wound surgically closed during hospitalization will be discharged with negative pressure
      wound therapy for up to a total of four weeks of therapy. After discharge from the hospital,
      subjects will be seen twice weekly by home health, and will be evaluated in clinic every 7
      days (±7 days) up to a total of 16-week period or until 30 days after the wound heals.

      Study Procedures:

      Screening Procedures

        -  Review and sign the Informed Consent and HIPAA Authorization

        -  The study doctor will review the inclusion and exclusion criteria

        -  Demographics (such as age, gender, race or ethnicity)

        -  Physical exam

        -  Sitting blood pressure and pulse

        -  Height and weight

        -  Collection of the medical and surgical history

        -  Collection of the history of the wound

        -  Wound assessment(s)/Debridement - various tests and measurements to assess the sensation
           (feeling) and circulation (blood flow) in the subject's feet and lower legs. None of
           these tests are invasive (using needles), uncomfortable or have risks greater than
           standard care.

        -  Wound imaging - photographs and images of the subject's wound using acetate tracings, a
           digital camera and an ARANZ camera (a special type of camera that uses computer software
           to calculate the volume of the wound)

        -  Hyperspectral imaging

        -  Vascular/Neurological evaluation

        -  Results of standard-of-care laboratory tests including a white blood cell count, blood
           chemistry (tests to see how well organs, such as the liver and kidneys are working), and
           blood glucose. Results of a serum pregnancy test (standard care for women of
           child-bearing potential as part of pre-op labs) will also be collected. About 2
           tablespoons of blood will be drawn for these tests.

        -  Collection of a list of the subject's current medications, including prescriptions,
           over-the-counter medications, supplements and herbals.

      This visit will last about 2 hours.

      If the subject qualifies for the study, they will participate in the following procedures:

      Group Assignment

      If the researchers believe the subject can take part in this study, s/he will be assigned
      randomly (like a flip of a coin) to receive one of the following therapies:

        -  Negative Pressure Wound Therapy with Irrigation

        -  Negative Pressure Wound Therapy without Irrigation

      The group is assigned randomly (like flipping a coin). The sponsor or researchers do not know
      in advance what group assignment each subject will receive. Neither the subject nor the
      researchers will be allowed to choose which group s/he is assigned to.

      Study Intervention

      The subject will receive either:

        -  Cardinal Pro +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with
           Prontosan®, or

        -  Cardinal Pro (NPWT) Therapy (without Prontosan®)

      Assigned therapy will continue in the hospital until the physician determines that the wound
      is ready for closure. If the subject's wound is healing, study therapy will be discontinued
      and standard dressings will be applied. If surgical closure is needed, the subject will
      return to the Operating Room for a procedure to close the wound.

      If the wound is not ready for closure during the hospital stay, subjects will continue NPWT
      at home for the remainder of the 4 weeks of treatment. NPWT at home will be without
      irrigation (KCI VAC Via®).

      Procedures and Evaluations during the Research The study therapy will only be given while the
      subject is in the hospital. S/he will continue the therapy for up to 4 weeks or until the
      wound is closed. Once the therapy is stopped s/he will continue to be followed by the study
      doctor. After the subject is released from the hospital s/he will need to see the study
      doctor Every 7 days (±7 days). If the subject's wound does not heal before 56 days after
      his/her first surgery then s/he will no longer be taking part in the study. The study doctor
      will continue to check the wound. If the wound closes, s/he will see the study doctor 30 days
      later to have the closed wound checked.

      12 Month Extension:

      After the end of the defined study period, the patients will be followed observationally by
      their electronic medical records for 12 months as it would not be feasible to ask them to
      return for an in-person evaluation as: patients have moved, no longer have correct contact
      information, as well as it would create a financial hardship on the patients to return for
      further visits. In order to more appropriately determine long term results from
      participation, a longer period of time of follow up is necessary. Related outcomes that we
      would like to follow over a 12-month duration are incidence of new foot ulcerations,
      re-ulceration of a previously healed foot wound, healing and time to healing of patients who
      took longer than the current study allows, duration of antibiotics received for foot
      infections, re-admissions to the hospital, need for subsequent surgery, amputation, loss of
      limb, and death. This expanded follow up period would provide valuable information to the
      long-term outcomes and complications of this high risk population and will help direct how
      future efforts may be better focused to reduce complications and improve outcomes.
    

Intervention name(s): Cardinal Pro +Simultaneous Irrigation (NPWTi); Cardinal Pro (NPWT) Therapy
Intervention type(s): Device; Device
Intervention description(s): NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®; NPWT 125 mm Hg continuous pressure with foam interface
Other intervention name(s): • Negative Pressure Wound Therapy with Irrigation; • Negative Pressure Wound Therapy without Irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment