Wound Healing, Diabetic
Conditions
Keywords
wound healing, diabetes wound healing
Brief 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.
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.
Interventions
Sponsors
Hospital General de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
A randomized clinical trial study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing:Number of cells per clauster in tissue sample of wound. | 15 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biochemical serum values of CPR | 15 days | To evaluate and compared the values of serum CPR, two different serum samples ( at the beginning and after finished the supplementation) |
| Biochemical serum values of creatinine | 15 days | To evaluate and compared the values of serum creatinine, two different serum samples ( at the beginning and after finished the supplementation) |
| Biochemical serum values of procalcitonine | 15 days | To evaluate and compared the values of serum procalcitonine, two different serum samples ( at the beginning and after finished the supplementation) |
| Bacterial growth per clauster in culture wound | 15 days | 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. |
| Bates- Jensen wound tool | 15 days | 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 |
| Glucemic control by glucose | 15 days | Glucose control will be messured in serum sample (mg/dL) in two different moments: at the begining and after finished the supplementation. |
| Glucemic control by HbA1c | 15 days | HbA1c(%) control will be messured in serum in two different moments: at the begining and after finished the supplementation. |
| Incidence of treatment- adverse events | 15 days | Each day of supplementation will be performed a questionary about subjective syntoms( as abdominal pain, diarrhea, nausea, vomiting, constipation or others) of supplementation, |
| Type of bacterial growth in wound | 15 days | 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. |
Countries
Mexico
Contacts
Primary ContactVanessa Fuchs, PhD
Outcome results
None listed