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Nutritional Regulation of Wound Inflammation: Part III

NCT02332993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2019-07-23

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

FPP

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..

Sponsors & Collaborators

  • Osato Research Institute

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Sashwati Roy, Ph.D · Ohio State University

Eligibility

Min Age
30 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-09-08
Completion
2018-02-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02332993 on ClinicalTrials.gov