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Negative Pressure TherapyFPP3NCT02332993

Nutritional Regulation of Wound Inflammation: Part III

An observational study of Negative Pressure Therapy and Wound, run by Ohio State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 30 to 30 years
Conditions the study is for
Negative Pressure Therapy, Wound, Open Wound
What is being tested?
FPP
How many people
22 participants
Where
2 sitesUnited States
Study dates
Dec 2014to 10 Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Type 2 Diabetic patients that are recieving negative pressure therapy for a wound.

Who may be able to join

  • 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:
Show all 9Show fewer
  • Transcutaneous Oxygen Measurement >30 mmHg
  • ABI (Ankle-Brachial Index) >0.7 and less 1.3
  • Toe Pressures >30 mmHg

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University East Hospital

    Columbus, Ohio, 43205

  • Martha Morehouse Medical Plaza

    Columbus, Ohio, 43221

Other trials in United States

About this study

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

Read the 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.

Being tested
FPP
Keywords
FPP (Fermented Papaya Preparation), Negative Pressure Therapy, Wound Vac, Wound, Type II Diabetic
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FPPDietary supplement

    Also called Fermented Papaya Preparation, Immun'Age, Osato

    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..

Study groups in NCT02332993
Study groupRoleWhat they receive
Supplementation Group15 Type 2 Diabetics receiving Negative Wound Pressure Therapy will receive the FPP supplementation to take 3 times a day for 12 weeks (3g/dose).
Receives: Dietary Supplement: FPP
Control Group15 Type 2 Diabetics receiving Negative Wound Pressure Therapy will receive no supplementation for 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

Secondary outcomes (3)

  1. Wound macrophage function

    Association of changes in wound macrophage function with wound area

    Measured: 12 weeks

  2. Wound Macrophage function

    Associations of change in wound macrophage function with cost of care

    Measured: 12 weeks

  3. Wound Macrophage function

    Association of change in wound macrophage function with amputation rate

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completion8 Sep 2016
  4. Study completion10 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02332993
Sponsor's protocol ID
20141371
Acronym
FPP3
Status last verified
Jul 2019
First submitted
2 Jan 2015
Last updated
23 Jul 2019
Results posted
No
Data monitoring committee
No

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.

    PubMed 6295574

  • Wheat LJ. Infection and diabetes mellitus. Diabetes Care. 1980 Jan-Feb;3(1):187-97. doi: 10.2337/diacare.3.1.187.

    PubMed 6996964

  • 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.

    PubMed 1341610

  • 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.

    PubMed 4809622

  • 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.

    PubMed 4403194

  • 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.

    PubMed 10575137

  • 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.

    PubMed 24176

  • 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.

    PubMed 8618487

  • 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.

    PubMed 8591699

  • 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.

    PubMed 18468758

  • Nau JY. [The Pope and the enlightenment of fermented papaya]. Rev Med Suisse. 2005 Feb 9;1(6):459. No abstract available. French.

    PubMed 15786653

  • 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.

    PubMed 9635126

  • 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.

    PubMed 12659174

  • 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.

    PubMed 15247013

  • 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.

    PubMed 16823100

Questions about this trial

What is this clinical trial studying?

An observational study of Negative Pressure Therapy and Wound, run by Ohio State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Macrophage ROS production and NADPH oxidase expression (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02332993, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

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