Nutritional Regulation of Wound Inflammation: Part III

NCT02332993 | Completed

• 1 other identifier: 20141371
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (2)

• Wound Macrophage ROS production and NADPH oxidase expression

  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

  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

Secondary Outcomes (3)

• Wound macrophage function

  12 weeks

• Wound Macrophage function

  12 weeks

• Wound Macrophage function

  12 weeks

Study Arms (2)

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).

Dietary Supplement: FPP

Control Group

15 Type 2 Diabetics receiving Negative Wound Pressure Therapy will receive no supplementation for 12 weeks.

Interventions

FPP DIETARY_SUPPLEMENT

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..

Also known as: Fermented Papaya Preparation, Immun'Age, Osato

Supplementation Group

Eligibility Criteria

• Age: 30 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Osato Research Institute: collaborator

Study Sites (2)

University East Hospital

Columbus, Ohio, 43205, United States

Location

Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Wounds and Injuries

Interventions

fermented papaya preparation

Study Officials

• Sashwati Roy, Ph.D

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 7, 2015
• Study Start: December 1, 2014
• Primary Completion: September 8, 2016
• Study Completion: February 10, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (2)