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Nutritional Regulation of Wound Inflammation: Part III (FPP3)

19 juli 2019 uppdaterad av: Ohio State University
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

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

22

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Ohio
      • Columbus, Ohio, Förenta staterna, 43221
        • Martha Morehouse Medical plaza
      • Columbus, Ohio, Förenta staterna, 43205
        • University East Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år till 30 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Type 2 Diabetic patients that are recieving negative pressure therapy for a wound.

Beskrivning

Inclusion Criteria:

  • Patients 30 - 70 years
  • Patient must understand and give written informed consent
  • Patient must be a Type II Diabetic
  • HbA1c ≤9%
  • Receiving Negative Pressure Therapy (NPWT)

One or more of the following:

  • Transcutaneous Oxygen Measurement >30 mmHg
  • ABI (Ankle-Brachial Index) >0.7 and less 1.3
  • Toe Pressures >30 mmHg

Exclusion Criteria:

  • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. Informed consent will be excluded.
  • Patients who are pregnant (all women of childbearing age will have a urine Hcg test upon enrollment and agree upon one of the following forms of contraception for the duration of the study: Abstinence, Hormonal contraception, spermicidal condoms, or either you or your partner having been surgically sterilized)
  • Immuno-compromised patients; receiving radiation therapy, chemo, or have gone through transplantation or other conditions with prolonged steroid use
  • Patients with clinical signs of soft tissue infection such as fever, erythema, leukocytosis, purulent drainage.
  • Antibiotic use 7 days prior to biopsy and cultures
  • Current smoker
  • Clinically significant kidney or liver disease (dialysis)
  • Severe neurologic dysfunction

Females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Supplementation Group
15 Type 2 Diabetics receiving Negative Wound Pressure Therapy will receive the FPP supplementation to take 3 times a day for 12 weeks (3g/dose).
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..
Andra namn:
  • Fermented Papaya Preparation
  • Immun'Age
  • Osato
Control Group
15 Type 2 Diabetics receiving Negative Wound Pressure Therapy will receive no supplementation for 12 weeks.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Wound Macrophage ROS production and NADPH oxidase expression
Tidsram: 12 weeks
determine the effect of Oral supplementation of FPP on wound macrophage ROS (reactive oxygen species rod outer segment) production and NADPH oxidase expression (RAC levels) in adult T2DM patients with wounds receiving negative pressure therapy
12 weeks
Wound Fluid inflammatory cytokine levels
Tidsram: 12 weeks
Determine the effect of oral supplementation of FPP on wound fluid inflammatory cytokine levels in adult Type 2 Diabetics Mellitus patients with wounds receiving negative pressure therapy
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Wound macrophage function
Tidsram: 12 weeks
Association of changes in wound macrophage function with wound area
12 weeks
Wound Macrophage function
Tidsram: 12 weeks
Associations of change in wound macrophage function with cost of care
12 weeks
Wound Macrophage function
Tidsram: 12 weeks
Association of change in wound macrophage function with amputation rate
12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Sashwati Roy, Ph.D, Ohio State University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2014

Primärt slutförande (Faktisk)

8 september 2016

Avslutad studie (Faktisk)

10 februari 2018

Studieregistreringsdatum

Först inskickad

2 januari 2015

Först inskickad som uppfyllde QC-kriterierna

5 januari 2015

Första postat (Uppskatta)

7 januari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juli 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 juli 2019

Senast verifierad

1 juli 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20141371

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