Nutritional Regulation of Wound Inflammation: Part III

Wound Clinical Trial

— FPP3  

Official title:

Nutritional Regulation of Wound Inflammation: Part III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332993
• Other study ID #: 20141371
• Status: Completed
• Start date: December 2014
• Est. completion date: February 10, 2018

Study information

• Verified date: July 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 10, 2018
• Est. primary completion date: September 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Inflammation
• Negative Pressure Therapy
• Open Wound
• Type II Non-Obese Diabetic
• Type II Obese Diabetic
• Wound
• Wounds and Injuries

Intervention

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..

Locations

Country	Name	City	State
United States	Martha Morehouse Medical Plaza	Columbus	Ohio
United States	University East Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Osato Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Rimbach G, Park YC, Guo Q, Moini H, Qureshi N, Saliou C, Takayama K, Virgili F, Packer L. Nitric oxide synthesis and TNF-alpha secretion in RAW 264.7 macrophages: mode of action of a fermented papaya preparation. Life Sci. 2000 Jun 30;67(6):679-94. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Wound macrophage function	Association of changes in wound macrophage function with wound area	12 weeks
Secondary	Wound Macrophage function	Associations of change in wound macrophage function with cost of care	12 weeks
Secondary	Wound Macrophage function	Association of change in wound macrophage function with amputation rate	12 weeks