Nutritional Regulation of Wound Inflammation: Part III

Completed

Conditions studied: Negative Pressure Therapy, Wound, Open Wound, Type II Obese Diabetic, Type II Non-Obese Diabetic

In brief

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

Key facts

Study ID

NCT02332993

Run by

Ohio State University

People needed

22

Starts

2014-12-01

Expected to finish

2018-02-10

Last updated by the study team

2019-07-23

Who can join

Age: 30 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University East Hospital — Columbus, Ohio, United States
• Martha Morehouse Medical Plaza — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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