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AzTrials

Wound HealingPhase 4NCT03782155

Effect of Supplementation With HMB and Glutamine in Wound Healing on Bloody Areas

A Phase 4 study testing glutamine supplementation and HMB in people with Wound Healing and Diabetic, run by Hospital General de Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A randomized controlled clinical trial in two groups of supplementation with HMB and glutamine. Each group consist in 25 patients with bloody areas, one group will receive and intervention with HMB and Glutamine and the other will receive a placebo with calcium caseinate. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Wound Healing, Diabetic
What is being tested?
glutamine supplementation and HMB
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteMexico
Study dates
1 Jun 2021to 31 Dec 2021
Phase
Phase 4
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with bloody areas at hospital admission
  • Hospital length stay around 15 days
  • Medical treatment with surgical washing and negative pressure systems
  • For the groups with diabetes, patients with diagnosis of type 2 diabetes with bloody areas.
  • Patients that accepts and signs the informative consent.

Who cannot join

  • patients with cancer or immunodeficiency
  • patients with HbA1c < 12
  • patients with collagen disease
  • patients with allergy to intervention substances (HMB, glutamine)

Trial locations and contacts

1 site in 1 country.

Vanessa Fuchs, PhD contact

551 85331635

vanessafuchs@gmail.com

Mexico1 site

  • Hospital General de México

    Mexico City

Other trials in Mexico

About this study

Official title: Effect of Supplementation With b- Hydroxy Methyl Butyrate and Glutamine in Wound Healing Histology in Type 2 Diabetes and Controls Bloody Areas

A randomized controlled clinical trial in two groups of supplementation with HMB and glutamine. Each group consist in 25 patients with bloody areas, one group will receive and intervention with HMB and Glutamine and the other will receive a placebo with calcium caseinate.

Read the detailed description

A fundamental part of the integral management of wound healing in patients with bloody areas is nutrition, since it involves biochemical events that depend on the substrates it provides. Wound healing is a phase that demands higher needs of energy-protein than the requirement. Problem statement: Poor nutrition decreases, through specific phases, normal processes that allow the progression of wound healing. Nutrient deficiencies can have negative effects on wound healing by prolonging the inflammatory phase, decreasing fibroblast proliferation, and modifying collagen synthesis. Some amino acids are essential for the process, such as Glutamine and Hydroxymethylbutyrate.

Objective: To evaluate the effect of Glutamine and Hydroxymethylbutyrate supplementation over the cells involved in wound healing of bloody areas. Hypothesis: Glutamine and Hydroxymethylbutyrate supplementation promotes a positive effect over the cells involved in wound healing of bloody areas. Methodology: A randomized controlled clinical trial, in patients with diagnosis of bloody areas. They will be divided into two groups, the first will receive an intervention with Glutamine (14g) and Hydroxymethylbutyrate (3g) and a control group will receive a placebo with calcium caseinate (17g)

A sample of the affected tissue will be taken before and after the supplementation where histology will be analyzed.

Remains of tissue will be obteined during surgery wash for histology.

Being tested
glutamine supplementation, HMB, Placebo
Keywords
wound healing, diabetes wound healing

What participants receive

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

  • glutamine supplementationDrug

    Also called Glutamine

    powder 14g

  • HMBDrug

    powder 3g

  • PlaceboDrug

    Also called Calcic caseinate

    powder 17g

Study groups in NCT03782155
Study groupRoleWhat they receive
HMB and glutamine supplementationExperimentalPatients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days.
Receives: Drug: glutamine supplementation; Drug: HMB
placebo patientsPlacebo comparatorPatients with type 2 diabetes with placebo( calcium caseinate) supplementation during 15 days 17g of powder once a day
Receives: Drug: Placebo

What is being measured

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

  1. Wound healing:Number of cells per clauster in tissue sample of wound.

    To evaluate the effect of supplementation in cellular differentiation. It will be counted and compared the number of cells per cluster in a tissue sample (lymphocytes, fibroblasts , macrophages and angiogeny) at the begining and after the supplementation.

    Measured: 15 days

Timeline

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

  1. First posted20 Dec 2018
  2. Study start1 Jun 2021 (estimated)
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized clinical trial study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03782155
Sponsor's protocol ID
DI/17/111/03/014
Status last verified
Sep 2020
First submitted
15 Oct 2018
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wild T, Rahbarnia A, Kellner M, Sobotka L, Eberlein T. Basics in nutrition and wound healing. Nutrition. 2010 Sep;26(9):862-6. doi: 10.1016/j.nut.2010.05.008.

    PubMed 20692599

  • Molnar JA, Vlad LG, Gumus T. Nutrition and Chronic Wounds: Improving Clinical Outcomes. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):71S-81S. doi: 10.1097/PRS.0000000000002676.

    PubMed 27556777

  • Stechmiller JK. Understanding the role of nutrition and wound healing. Nutr Clin Pract. 2010 Feb;25(1):61-8. doi: 10.1177/0884533609358997.

    PubMed 20130158

  • Gundogdu RH, Temel H, Bozkirli BO, Ersoy E, Yazgan A, Yildirim Z. Mixture of Arginine, Glutamine, and beta-hydroxy-beta-methyl Butyrate Enhances the Healing of Ischemic Wounds in Rats. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):1045-1050. doi: 10.1177/0148607115625221. Epub 2016 Jan 29.

    PubMed 26826258

  • Bozkirli BO, Gundogdu RH, Ersoy E, Lortlar N, Yildirim Z, Temel H, Oduncu M, Karakaya J. Pilot Experimental Study on the Effect of Arginine, Glutamine, and beta-Hydroxy beta-Methylbutyrate on Secondary Wound Healing. JPEN J Parenter Enteral Nutr. 2015 Jul;39(5):591-7. doi: 10.1177/0148607113520433. Epub 2014 Jan 24.

    PubMed 24463351

  • Armstrong DG, Hanft JR, Driver VR, Smith AP, Lazaro-Martinez JL, Reyzelman AM, Furst GJ, Vayser DJ, Cervantes HL, Snyder RJ, Moore MF, May PE, Nelson JL, Baggs GE, Voss AC; Diabetic Foot Nutrition Study Group. Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial. Diabet Med. 2014 Sep;31(9):1069-77. doi: 10.1111/dme.12509. Epub 2014 Jun 19.

    PubMed 24867069

  • Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.

    PubMed 24810310

  • Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen wound assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 2010 May-Jun;37(3):253-9. doi: 10.1097/WON.0b013e3181d73aab.

    PubMed 20386331

  • Salas-Gonzalez P, Sevilla- Gonzalez M de la L, Fuchs- Tarlovsky V. Effect of supplementation with glutamine and hydroxymethylbutirate over the cellsinvolved un wound healing. Int J Adv Res. 2018 Aug 31;6(8):100-6.

  • Sipahi S, Gungor O, Gunduz M, Cilci M, Demirci MC, Tamer A. The effect of oral supplementation with a combination of beta-hydroxy-beta-methylbutyrate, arginine and glutamine on wound healing: a retrospective analysis of diabetic haemodialysis patients. BMC Nephrol. 2013 Jan 12;14:8. doi: 10.1186/1471-2369-14-8.

    PubMed 23311725

  • Rathmacher JA, Nissen S, Panton L, Clark RH, Eubanks May P, Barber AE, D'Olimpio J, Abumrad NN. Supplementation with a combination of beta-hydroxy-beta-methylbutyrate (HMB), arginine, and glutamine is safe and could improve hematological parameters. JPEN J Parenter Enteral Nutr. 2004 Mar-Apr;28(2):65-75. doi: 10.1177/014860710402800265.

    PubMed 15080599

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing glutamine supplementation and HMB in people with Wound Healing and Diabetic, run by Hospital General de Mexico at 1 site in Mexico.

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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Vanessa Fuchs, PhD (551 85331635, vanessafuchs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound healing:Number of cells per clauster in tissue sample of wound. (time frame: 15 days). 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 NCT03782155, which also lists 11 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 3 Sep 2020.

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