At a glance

ClinicalIndex Comparison Record

N/ACompleted· 22 enrolled

Drug / intervention

FPPdietary

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02332993

NCT02332993N/ACompleted

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Nutritional Regulation of Wound Inflammation: Part III

Ohio State University·observational·Posted Jan 7, 2015·Updated Jul 23, 2019

In Brief

An observational study evaluating FPP for Negative Pressure Therapy and 4 related conditions. Completed, enrolled 22 participants across 2 sites.

Detailed 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

Study Details

Study Typeobservational

Allocation--

Masking--

Primary Purpose--

ConditionsNegative Pressure Therapy, Wound, Open Wound, Type II Obese Diabetic, Type II Non-Obese Diabetic

CountriesUnited States

CollaboratorsOsato Research Institute

Timeline

N/ACompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartDec 2014

First PostedJan 2015

Primary CompletionSep 2016

Study CompletionFeb 2018

TodayJul 2026

First PostedJan 7, 2015

Enrollment StartDec 1, 2014

Primary CompletionSep 8, 2016

Study CompletionFeb 10, 2018

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 11.5 years ago

Interventions

FPPdietary

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..