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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03782155
Other study ID # DI/17/111/03/014
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2021

Study information

Verified date September 2020
Source Hospital General de Mexico
Contact Vanessa Fuchs, PhD
Phone 551 85331635
Email vanessafuchs@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- patients with cancer or immunodeficiency

- patients with HbA1c < 12

- patients with collagen disease

- patients with allergy to intervention substances (HMB, glutamine)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
glutamine supplementation
powder 14g
HMB
powder 3g
Placebo
powder 17g

Locations

Country Name City State
Mexico Hospital General de México Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

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. — View Citation

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

Gündogdu RH, Temel H, Bozkirli BO, Ersoy E, Yazgan A, Yildirim Z. Mixture of Arginine, Glutamine, and ß-hydroxy-ß-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. — View Citation

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. — View Citation

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. Review. — View Citation

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 — View Citation

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. BM — View Citation

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

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Bates- Jensen wound tool To compared Bates- Jensen questionnaire will be applied two evaluations: first will be done before supplementation and second after finished the supplementation this scale consider physical characteristics of wound and give a punctuation 1 to 5 in each item ( size, depht, borders, necrosis, percentage of necrotic tissue , type of exudate, amount of exudate, skin color, edema, induration, granular tissue,epithelialization) according to this, items have a value that will be considered in a total punctuation of wound Punctuation 1-12 Health tissue 13- 59 regeneration 60. Degeneration 15 days
Other Biochemical serum values of CPR To evaluate and compared the values of serum CPR, two different serum samples ( at the beginning and after finished the supplementation) 15 days
Other Biochemical serum values of creatinine To evaluate and compared the values of serum creatinine, two different serum samples ( at the beginning and after finished the supplementation) 15 days
Other Biochemical serum values of procalcitonine To evaluate and compared the values of serum procalcitonine, two different serum samples ( at the beginning and after finished the supplementation) 15 days
Other Bacterial growth per clauster in culture wound It will be taken a bacterial culture of wound in two different moments ( at the beginning and after finished the supplementation) Will be counted the colony number per clauster and type of bacteria. 15 days
Other Type of bacterial growth in wound It will be taken a bacterial culture of wound in two different moments ( at the beginning and after finished the supplementation) will be counted the kind of bacteria. 15 days
Other Glucemic control by glucose Glucose control will be messured in serum sample (mg/dL) in two different moments: at the begining and after finished the supplementation. 15 days
Other Glucemic control by HbA1c HbA1c(%) control will be messured in serum in two different moments: at the begining and after finished the supplementation. 15 days
Other Incidence of treatment- adverse events Each day of supplementation will be performed a questionary about subjective syntoms( as abdominal pain, diarrhea, nausea, vomiting, constipation or others) of supplementation, 15 days
Primary 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. 15 days
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