Pressured Ulcers in I & II
Conditions
Interventions
Trade Name: Vioplex- T
Product Name: Vioplex-T
Product Code: 1949801
Pharmaceutical Form: Cutaneous spray, powder
Pharmaceutical form of the placebo: Cutaneous spray, powder
Route of administration o
Sponsors
D.A.S.T. BIOTECH PHARM ?.?.?.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with 1 to 3 pressure ulcers stage II and / or III. pressure ulcers being evaluated should have occurred at least 4 weeks prior to study initiation. In cases of patients who have more than one pressure ulcers but = 3, the pressure ulcer that will be selected for evaluation of treatment, from the investigator, is the one that needs the most time of healing. • Patient Age:> 18 years • Gender: Women - Men • Body Mass Index (BMI): = 30 kg/m2. Defined as the ratio of weight (in kilograms) by the square of height (in meters). For a definition of these limits are taken into account, the tables in World Health Organization (WHO). • Written consent from the patients for their participation in the study. • Negative pregnancy test for women of childbearing age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 101 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 101
Exclusion criteria
Exclusion criteria: • Patients = 18 years. • Pregnant or lactating women. • Lactating women. • Patients with pressure ulcers stage IV. • Patients with a single bedtime stage I. • Patients with cutaneous malignancies. • Patients with extensive injuries. • Patients with burns. • Patients with ulcers from other causes. • Patients with systemic infection. • Patients presenting with bacteremia. • Patients presenting with sepsis. • Patients presenting with advanced cellulite. • Patients presenting with osteomyelitis. • Patients with microbial load = 105 CFU/cm2 (Bill et al 2001, EPUAP-NPUAP 2009) in samples of liquid cultures of pressure ulcers. • Patients with known hypersensitivity to the active substance Bacitracin and other structurally related polypeptide antibiotics, the active ingredient Neomycin and other aminoglycosides, as well as a vehicle of study drug. • Patients with a history of: • renal and / or hepatic insufficiency. • diabetes. • peripheral vascular disease. • autoimmune diseases. • transplantation. • immunocompromised patients. • Patients undergoing major surgery 15 days before the study. • Patients with psychiatric disorders and / or drug users, which do not allow them to give informed consent or to follow therapeutic options or patients who do not want or are unable to comply with the protocol. • Patients with serum albumin <5,5 g / dL, albumins <2,5 g / dL, globulin <1,5 g / dL. • Use of tobacco: current tobacco use in any form six months prior to study • Use of alcohol: regular users of more than two units of alcohol a day (1 unit = 300 ml beer, 150 ml wine, 45 ml alcohol 40%) who can not abstain from alcohol for a period of 48 hours prior to the preparation of the study week until the end of that. • Abnormal eating habits: including vegetarian diets, excessive intake of vitamins, products containing creatine, dietary psychological disorders, recent significant weight change during the last 30 days prior to study entry. • Recent participation in study: taking any medication for their involvement in the study, in less than 60 days before the initial administration in this study. • History of non-compliance with medical regimens, or patients considered likely to be unstable and / or uncooperative, unwilling or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is the difference between the group of study drug and the placebo group with regard to the degree of healing of pressure ulcers after 4 weeks of treatment. The healing of pressure ulcers assessed the scale PUSH;Timepoint(s) of evaluation of this end point: 4 weeks;Main Objective: Evaluate the efficacy of topical treatment with VIOPLEX-T in the healing of pressure ulcers stage II and III after 4 weeks of application of it;Secondary Objective: The evaluation of local therapy VIOPLEX-T in reducing the microbial load in bedsores stage II and III | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The time course, within 4 weeks of price reduction scale PUSH for both teams. • The evaluation of topical treatment with the investigational drug in reducing the microbial load in pressure ulcers stage II and III • The assessment of the safety of topical treatment with the investigational drug.;Timepoint(s) of evaluation of this end point: The time course of the cumulative reduction in value of the scale PUSH and the difference between the two groups especially in the second week. • We will evaluate the difference between the group of study drug and placebo with regard to the extent of healing pressure ulcers every week measurement. • The time until reduction in scale PUSH least two points below the original estimate. • The time course of the cumulative reduction of microbial load in samples of liquid cultures of pressure ulcers and the difference between the two groups especially in the 2nd and 4th week. • will evaluate the difference in the reduction of the microbial load in cultures of samples of fluid pressure ulcers between the two groups in each week measurement. | — |
Countries
Greece
Contacts
Public ContactICI
INSTITUTE FOR CLINICAL INVESTIGATION
Outcome results
None listed