Nutritional Regulation of Wound Inflammation: Part III

Completed

• Conditions: Type II Obese Diabetic; Type II Non-Obese Diabetic; Wound; Open Wound; Negative Pressure Therapy
• Interventions: Dietary Supplement: FPP

• Registration Number: NCT02332993
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Primary Completion: 2016-09-08
• Study Completion: 2018-02-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-19
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Supplementation Group	FPP	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).

Primary Outcome Measures

Name	Time	Method
Wound Fluid inflammatory cytokine levels	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
Wound Macrophage ROS production and NADPH oxidase expression	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

Secondary Outcome Measures

Name	Time	Method
Wound macrophage function	12 weeks	Association of changes in wound macrophage function with wound area
Wound Macrophage function	12 weeks	Association of change in wound macrophage function with amputation rate

Trial Locations

Locations (2)

University East Hospital; 🇺🇸 Columbus, Ohio, United States

Martha Morehouse Medical Plaza; 🇺🇸 Columbus, Ohio, United States