- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02332993
Nutritional Regulation of Wound Inflammation: Part III (FPP3)
19. července 2019 aktualizováno: 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
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
22
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43221
- Martha Morehouse Medical Plaza
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Columbus, Ohio, Spojené státy, 43205
- University East Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
30 let až 30 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
Type 2 Diabetic patients that are recieving negative pressure therapy for a wound.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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..
Ostatní jména:
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Wound Macrophage ROS production and NADPH oxidase expression
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Wound macrophage function
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Sashwati Roy, Ph.D, Ohio State University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2014
Primární dokončení (Aktuální)
8. září 2016
Dokončení studie (Aktuální)
10. února 2018
Termíny zápisu do studia
První předloženo
2. ledna 2015
První předloženo, které splnilo kritéria kontroly kvality
5. ledna 2015
První zveřejněno (Odhad)
7. ledna 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. července 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. července 2019
Naposledy ověřeno
1. července 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 20141371
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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