Nutritional Regulation of Wound Inflammation: Part III
Condition: Negative Pressure Therapy; Wound; Open Wound; Type II Obese Diabetic; Type II Non-Obese Diabetic
MeSH terms: Inflammation; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to examine the changes that result in the wound healing of a
      type II Diabetic using Negative Pressure Therapy after 12 weeks of daily supplementation of
      ImmunAge (Fermented Papaya Preparation (FPP). ImmunAge (FPP) is a supplement made from Carica
      papaya Linn and is available over the counter. ImmunAge (FPP) is an investigational drug,
      which means it has not been approved by the U. S. Food and Drug Administration (FDA).
      Approximately 30 subjects will participate in this study. 15 subjects will take the
      supplementation and 15 subjects to take no supplementation as the control. The
    

Detailed description: 
      There are a total of 3 study visits over the course of the 12 weeks of the study that will
      include procedures such as collection of their wound dressing, imaging, blood draw, and
      receiving the supplement (if in supplementation group). These visits will occur at weeks 0
      (consent signed and first distribution of supplements), 2, 3, and 12. At the initial visit
      the following will be recorded: birth year, gender, ethnicity, race, women of child bearing
      age: current form of birth control, negative or positive urine Hcg, current medications
      (medication, dose, frequency, diagnosis), allergies, past or present medical problems, height
      and weight, HbA1c value, wound site, wound etiology, Blood pressure, pulse, and if the
      subjects will be randomized into either the control or supplementation group. Subjects will
      return one week later for study visit one where their blood pressure and pulse will be
      recorded and will also have one of the following tests completed as a screen fail for the
      study: Transcutaneous Oxygen Measurement, Toe Pressure, or Ankle-Brachial Index Test. If the
      reading is inadequate then the subject will no longer participate in the study. Their wound
      vac sponge will be collected and imaging will be obtained. Subjects will return for study
      visit 2 where they will have their blood pressure and pulse recorded, will have a blood draw,
      wound vac sponge collected and wound imaging obtained. Subjects will be asked to return after
      12 weeks of supplementation and will have their blood pressure and pulse recorded and wound
      imaging obtained. Subjects will be asked to bring any empty packets of the supplement to each
      visit for compliance and will be given a new supply of supplements at the initial visit,
      visit 1 and 2. Note, if a subject is discontinued from the negative pressure therapy within 2
      weeks of consent then the subject will be dropped from the study.
    

Intervention name(s): FPP
Intervention type(s): Dietary Supplement
Intervention description(s): Made from Carica papaya and represents a sweet and granular substance available over the counter. FPP possesses antioxidant properties that can provide benefit against age-related complications..
Other intervention name(s): Fermented Papaya Preparation; Immun'Age; Osato
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type 2 Diabetic patients that are recieving negative pressure therapy for a wound.
      
Biospecimen description: 
      Blood
    
Keywords: FPP (Fermented Papaya Preparation); Negative Pressure Therapy; Wound Vac; Wound; Type II Diabetic