- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332993
Nutritional Regulation of Wound Inflammation: Part III (FPP3)
July 19, 2019 updated by: Ohio State University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43221
- Martha Morehouse Medical Plaza
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Columbus, Ohio, United States, 43205
- University East Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Type 2 Diabetic patients that are recieving negative pressure therapy for a wound.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
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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..
Other Names:
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Control Group
15 Type 2 Diabetics receiving Negative Wound Pressure Therapy will receive no supplementation for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Macrophage ROS production and NADPH oxidase expression
Time Frame: 12 weeks
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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
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12 weeks
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Wound Fluid inflammatory cytokine levels
Time Frame: 12 weeks
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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
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound macrophage function
Time Frame: 12 weeks
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Association of changes in wound macrophage function with wound area
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12 weeks
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Wound Macrophage function
Time Frame: 12 weeks
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Associations of change in wound macrophage function with cost of care
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12 weeks
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Wound Macrophage function
Time Frame: 12 weeks
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Association of change in wound macrophage function with amputation rate
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sashwati Roy, Ph.D, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Babior BM. The enzymatic basis for O-.2 production by human neutrophils. Can J Physiol Pharmacol. 1982 Nov;60(11):1353-8. doi: 10.1139/y82-202.
- Wheat LJ. Infection and diabetes mellitus. Diabetes Care. 1980 Jan-Feb;3(1):187-97. doi: 10.2337/diacare.3.1.187.
- Carton JA, Maradona JA, Nuno FJ, Fernandez-Alvarez R, Perez-Gonzalez F, Asensi V. Diabetes mellitus and bacteraemia: a comparative study between diabetic and non-diabetic patients. Eur J Med. 1992 Sep;1(5):281-7.
- Bagdade JD, Root RK, Bulger RJ. Impaired leukocyte function in patients with poorly controlled diabetes. Diabetes. 1974 Jan;23(1):9-15. doi: 10.2337/diab.23.1.9. No abstract available.
- Bagdade JD, Nielson KL, Bulger RJ. Reversible abnormalities in phagocytic function in poorly controlled diabetic patients. Am J Med Sci. 1972 Jun;263(6):451-6. doi: 10.1097/00000441-197206000-00005. No abstract available.
- Geerlings SE, Hoepelman AI. Immune dysfunction in patients with diabetes mellitus (DM). FEMS Immunol Med Microbiol. 1999 Dec;26(3-4):259-65. doi: 10.1111/j.1574-695X.1999.tb01397.x.
- Babior BM. Oxygen-dependent microbial killing by phagocytes (first of two parts). N Engl J Med. 1978 Mar 23;298(12):659-68. doi: 10.1056/NEJM197803232981205. No abstract available.
- Dandona P, Thusu K, Cook S, Snyder B, Makowski J, Armstrong D, Nicotera T. Oxidative damage to DNA in diabetes mellitus. Lancet. 1996 Feb 17;347(8999):444-5. doi: 10.1016/s0140-6736(96)90013-6.
- Chang FY, Shaio MF. Respiratory burst activity of monocytes from patients with non-insulin-dependent diabetes mellitus. Diabetes Res Clin Pract. 1995 Aug;29(2):121-7. doi: 10.1016/0168-8227(95)01123-4.
- Anuar NS, Zahari SS, Taib IA, Rahman MT. Effect of green and ripe Carica papaya epicarp extracts on wound healing and during pregnancy. Food Chem Toxicol. 2008 Jul;46(7):2384-9. doi: 10.1016/j.fct.2008.03.025. Epub 2008 Apr 3.
- Nau JY. [The Pope and the enlightenment of fermented papaya]. Rev Med Suisse. 2005 Feb 9;1(6):459. No abstract available. French.
- Imao K, Wang H, Komatsu M, Hiramatsu M. Free radical scavenging activity of fermented papaya preparation and its effect on lipid peroxide level and superoxide dismutase activity in iron-induced epileptic foci of rats. Biochem Mol Biol Int. 1998 Jun;45(1):11-23. doi: 10.1080/15216549800202392.
- 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. doi: 10.1016/s0024-3205(00)00664-0.
- Marotta F, Barreto R, Tajiri H, Bertuccelli J, Safran P, Yoshida C, Fesce E. The aging/precancerous gastric mucosa: a pilot nutraceutical trial. Ann N Y Acad Sci. 2004 Jun;1019:195-9. doi: 10.1196/annals.1297.031.
- Aruoma OI, Colognato R, Fontana I, Gartlon J, Migliore L, Koike K, Coecke S, Lamy E, Mersch-Sundermann V, Laurenza I, Benzi L, Yoshino F, Kobayashi K, Lee MC. Molecular effects of fermented papaya preparation on oxidative damage, MAP Kinase activation and modulation of the benzo[a]pyrene mediated genotoxicity. Biofactors. 2006;26(2):147-59. doi: 10.1002/biof.5520260205.
- Calzuola I, Gianfranceschi GL, Marsili V. Comparative activity of antioxidants from wheat sprouts, Morinda citrifolia, fermented papaya and white tea. Int J Food Sci Nutr. 2006 May-Jun;57(3-4):168-77. doi: 10.1080/09637480600658328.
- Marotta F, Pavasuthipaisit K, Yoshida C, Albergati F, Marandola P. Relationship between aging and susceptibility of erythrocytes to oxidative damage: in view of nutraceutical interventions. Rejuvenation Res. 2006 Summer;9(2):227-30. doi: 10.1089/rej.2006.9.227.
- Marotta F, Weksler M, Naito Y, Yoshida C, Yoshioka M, Marandola P. Nutraceutical supplementation: effect of a fermented papaya preparation on redox status and DNA damage in healthy elderly individuals and relationship with GSTM1 genotype: a randomized, placebo-controlled, cross-over study. Ann N Y Acad Sci. 2006 May;1067:400-7. doi: 10.1196/annals.1354.057.
- Amer J, Goldfarb A, Rachmilewitz EA, Fibach E. Fermented papaya preparation as redox regulator in blood cells of beta-thalassemic mice and patients. Phytother Res. 2008 Jun;22(6):820-8. doi: 10.1002/ptr.2379.
- Dawkins G, Hewitt H, Wint Y, Obiefuna PC, Wint B. Antibacterial effects of Carica papaya fruit on common wound organisms. West Indian Med J. 2003 Dec;52(4):290-2.
- Gurung S, Skalko-Basnet N. Wound healing properties of Carica papaya latex: in vivo evaluation in mice burn model. J Ethnopharmacol. 2009 Jan 21;121(2):338-41. doi: 10.1016/j.jep.2008.10.030. Epub 2008 Nov 8.
- Mikhal'chik EV, Ivanova AV, Anurov MV, Titkova SM, Pen'kov LY, Kharaeva ZF, Korkina LG. Wound-healing effect of papaya-based preparation in experimental thermal trauma. Bull Exp Biol Med. 2004 Jun;137(6):560-2. doi: 10.1023/b:bebm.0000042711.31775.f7.
- Nayak SB, Pinto Pereira L, Maharaj D. Wound healing activity of Carica papaya L. in experimentally induced diabetic rats. Indian J Exp Biol. 2007 Aug;45(8):739-43.
- Pieper B, Caliri MH. Nontraditional wound care: A review of the evidence for the use of sugar, papaya/papain, and fatty acids. J Wound Ostomy Continence Nurs. 2003 Jul;30(4):175-83. doi: 10.1067/mjw.2003.131.
- Khanna S, Biswas S, Shang Y, Collard E, Azad A, Kauh C, Bhasker V, Gordillo GM, Sen CK, Roy S. Macrophage dysfunction impairs resolution of inflammation in the wounds of diabetic mice. PLoS One. 2010 Mar 4;5(3):e9539. doi: 10.1371/journal.pone.0009539.
- Collard E, Roy S. Improved function of diabetic wound-site macrophages and accelerated wound closure in response to oral supplementation of a fermented papaya preparation. Antioxid Redox Signal. 2010 Sep 1;13(5):599-606. doi: 10.1089/ars.2009.3039.
- Marotta F, Koike K, Lorenzetti A, Naito Y, Fayet F, Shimizu H, Marandola P. Nutraceutical strategy in aging: targeting heat shock protein and inflammatory profile through understanding interleukin-6 polymorphism. Ann N Y Acad Sci. 2007 Nov;1119:196-202. doi: 10.1196/annals.1404.011.
- Thiele JJ, Traber MG, Packer L. Depletion of human stratum corneum vitamin E: an early and sensitive in vivo marker of UV induced photo-oxidation. J Invest Dermatol. 1998 May;110(5):756-61. doi: 10.1046/j.1523-1747.1998.00169.x.
- Das A, Dickerson R, Ghatak PD, Gordillo GM, Chaffee S, Saha A, Khanna S, Roy S. May Dietary Supplementation Augment Respiratory Burst in Wound-Site Inflammatory Cells? Antioxid Redox Signal. 2018 Feb 10;28(5):401-405. doi: 10.1089/ars.2017.7304. Epub 2017 Oct 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
September 8, 2016
Study Completion (Actual)
February 10, 2018
Study Registration Dates
First Submitted
January 2, 2015
First Submitted That Met QC Criteria
January 5, 2015
First Posted (Estimate)
January 7, 2015
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 19, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20141371
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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