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Report for Clinical Trial NCT02578004

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients

Development of pressure ulcer (PU) is complex and multifactorial. The association of a constituted PU and of clinical / biological major elements is demonstrated and justifies. Prevention of PU is an important health priority, one that requires clear identification of risk factors.

NCT02578004 Pressure Ulcers
MeSH:Pressure Ulcer Ulcer
HPO:Pressure ulcer

1 Interventions

Name: biochemical and molecular analysis

Type: Other
Group Labels: 2

100 patients suffering from pressure ulcer 213 healthy subjects


Primary Outcomes

Description: Body Mass Index (BMI) is a simple index of weight-for-height. It is defined as the weight in kilograms divided by the square of the height in metres (kg/m2).

Measure: Anthropometric characteristics

Time: one hour

Description: - Plasma levels glucose in mmol/l was measured by standard enzymatic methods using reagents in a fully automated analyzer Cx5 Pro-Bechman Coulter-Fuller-Ton

Measure: Diabetes mellitus

Time: one hour

Description: Lipid markers: total serum cholesterol (CH), serum triglyceride, serum HDL- CH, in mmol/l, levels were measured by standard enzymatic methods using reagents in a fully automated analyzer (Randox Antrim, UK; CX9-BECKMANN). Low density lipoprotein cholesterol (LDL-C) in mmol / l was determined by Friedewald formula. non esterified fatty acids in serum was determined by colorimetric method at 550 nm (mmol/l)

Measure: Dyslipidemia

Time: one hour

Description: - renal profile: urea (mmol/l), creatinine and uric acid (μmol/l) levels were measured by standard enzymatic methods using reagents in a fully automated analyzer ( Cx9 Pro-Bechman Coulter-Fuller-Ton).

Measure: Renal failure

Time: one hour

Description: - C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).

Measure: Inflammatory parameter

Time: one hour

Description: - α1‐acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)

Measure: Endogenous inflammatory marker

Time: one hour

Description: albumin (chronic marker) and prealbumin (early marker) were measured, in g/l, using the dry chemistry method (BN prospec, siemens). Protide in g/l was measured by standard enzymatic methods using reagents in a fully automated analyzer (CX9-BECKMANN).

Measure: Markers of nutritional status

Time: one hour

Description: Serum total homocysteine concentrations in μmol/l were measured by using an AxSYM (ABBOTT) homocysteine assay. thiobarbituric acid reactive substances (TBARS) in serum was determined by the fluorimetric method of Yagi in μmol/l.

Measure: Marker of lipid peroxidation

Time: one day

Description: - Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .

Measure: Antioxidant parameters

Time: one day

Description: Serum total antioxidant status in mmol/l was measured with RANDOX kit (Cat. No. NZ 2332; Randox Labs Ltd., Crumlin, UK) by colorimetric method at 600 nm .

Measure: Total antioxidant status

Time: one hour

Description: Serum copper in μmol/l was indicated spectrophotometrically with RANDOX kit (Cat. No. CU 2340; Randox Labs Ltd., Crumlin, UK) at 580 nm according. Serum zinc was measured in μmol/l with RANDOX kit (Cat. No. ZN 2341; Randox Labs Ltd, Crumlin, UK) at 560 nm.

Measure: Determination of trace elements

Time: one hour

Description: - Nutritional Risk Index (NRI) was originally derived from the serum albumin concentration and the ratio of present to usual weight [NRI = (1.489 x albumin, g/L) + (41.7 x present weight/ideal body weight)] and categorized as follows: severe risk (NRI < 83.5), moderate risk (83.5 < NRI < 97.5) and no risk (NRI > 97.5).

Measure: Nutritional status

Time: 3 hours

Description: - Prognostic Inflammatory and Nutritional Index (PINI) is a simple clinical [PINI = AAG x CRP / albumine x prealbumin] and classificated as follows: normal (130. These scores gained in popularity as it uses an objective rather than subjective measurements to determine nutritional risk in hospitalized patient populations.

Measure: Nutritional risk

Time: 3 hours

Description: The bacterial colonization of a wound is a recognized detrimental factor in the multifactorial process of wound healing. wound per patient suffering from pressure ulcer was cultured by swab to determine the bacterial species of the infection and helps guide antibiotic therapy. The representative sample is collected before topical or systemic antibiotics are initiated and pain assessment should be conducted prior to wound procedures such as dressing changes and debridement. Bacterial swabs provide information on the predominant flora.

Measure: A microbiological diagnosis

Time: 3 days

Description: - Serum gelatinase activities of MMP-9 by zymography (%)

Measure: Proteomics

Time: 2 days

Description: Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.

Measure: DNA extraction

Time: 2 days

Description: Genetic polymorphism in the MMP9 coding region 1562C>T was screened following the polymerase chain reaction and restriction fragment length polymorphism (RFLP-PCR). The frequency distributions of different MMP9-1562 C/T genotypes and allele were investigated. The relationship between the polymorphism of the MMP-9 gene and the severity of PU was analyzed.

Measure: Genotype for the MMP9-1562 C/T polymorphism

Time: 1 days

Description: TNF-α G238A promoter polymorphism were determined by the RFLP-PCR method. The genotypic and allelic frequencies of -238G/A were calculated This study investigated the association between TNF-α−238G>A and Pressure ulcer in Tunisian population.

Measure: Genotyping of TNF- α G238A

Time: 1 days

Description: The genotypic analysis of the TNF-α G308A polymorphism was performed using Allele-specific PCR (AS-PCR) amplification. In this study, we have analyzed the TNF-α gene promoter -308G/A polymorphism in Tunisian patients with PU to evaluate the contribution of this SNP in genetic susceptibility to PU.

Measure: Genotyping of TNF- α G308A

Time: 1 days

Time Perspective: Retrospective

Case Control


There are 2 SNPs

SNPs


1 G238A

The relationship between the polymorphism of the MMP-9 gene and the severity of PU was analyzed.. Genotyping of TNF- α G238A. --- G238A ---

TNF-α G238A promoter polymorphism were determined by the RFLP-PCR method. --- G238A ---


2 G308A

The genotypic and allelic frequencies of -238G/A were calculated This study investigated the association between TNF-α−238G>A and Pressure ulcer in Tunisian population.. Genotyping of TNF- α G308A. --- G308A ---

The genotypic analysis of the TNF-α G308A polymorphism was performed using Allele-specific PCR (AS-PCR) amplification. --- G308A ---



HPO Nodes


HPO: