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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Wound Healing, Diabetic

Intervention / Treatment
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* Drug: glutamine supplementation
* Drug: HMB
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical trial study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HMB and glutamine supplementation<br>Patients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days. | Drug: glutamine supplementation<br>* powder 14g<br>* Other names: Glutamine;Drug: HMB<br>* powder 3g<br>|
| Placebo Comparator: placebo patients<br>Patients with type 2 diabetes with placebo( calcium caseinate) supplementation during 15 days 17g of powder once a day | Drug: Placebo<br>* powder 17g<br>* Other names: Calcic caseinate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, diabetes wound healing