Clinical trial NCT02332993: Nutritional Regulation of Wound Inflammation: Part III
Official title: Nutritional Regulation of Wound Inflammation: Part III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Negative Pressure Therapy
Wound
Open Wound
Type II Obese Diabetic
Type II Non-Obese Diabetic
Keywords: FPP (Fermented Papaya Preparation)
Negative Pressure Therapy
Wound Vac
Wound
Type II Diabetic
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Osato Research Institute
First posted: 2015-01-07
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound Macrophage ROS production and NADPH oxidase expression
timeFrame: 12 weeks
measure: Wound Fluid inflammatory cytokine levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound macrophage function
timeFrame: 12 weeks
measure: Wound Macrophage function
timeFrame: 12 weeks
measure: Wound Macrophage function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: University East Hospital
state: Ohio
city: Columbus
country: United States
facility: Martha Morehouse Medical Plaza
state: Ohio
Study officials:
affiliation: Ohio State University
name: Sashwati Roy, Ph.D
role: PRINCIPAL_INVESTIGATOR
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