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The choice of suitable study populations in which to conduct large-scale phase III HIV prevention trials is a fundamental issue for communities, researchers, sponsors and donor organizations. In many developed and developing countries, such trials are feasible only among vulnerable, disadvantaged communities at high-risk of HIV and sexually transmitted infections, where high HIV incidence rates make randomised controlled efficacy trials feasible but where poverty, social exclusion, illiteracy, stigma and powerlessness mean ethical considerations are paramount. In such settings, preliminary feasibility studies are considered essential to inform the design of future phase III efficacy and safety trials. Researchers typically frame their assessment of feasibility within an ‘epidemiological paradigm’, focusing on a limited number of key biomedical outcome parameters to guide decision making. These include HIV, STI and pregnancy incidence; and the feasibility of recruiting and retaining sufficient numbers of subjects from a given study population. This Thesis argues that a more comprehensive assessment of feasibility, which combines epidemiological factors with other key constructs such as ethics and social justice, is critical to the successful conduct of high quality and ethically sound HIV prevention trials among vulnerable at-risk study populations in Africa. This work is based on a combination of epidemiological, applied social science and participatory action-orientated research conducted during a microbicide trial feasibility study and an on-going phase III randomised placebo-controlled efficacy and safety trial of the candidate vaginal microbicide PRO2000/5 Gel (Indevus Pharmaceuticals, USA) that I coordinated as the Clinical Site Principal Investigator in Tanzania from November 2002 until March 2007, and for which I remain a Co-Investigator. All fieldwork was carried out in Mwanza City, in the Lake Victoria basin region of northwest Tanzania, among an occupational cohort of women working in bars, guesthouses, hotels and other food outlets and recreational facilities. Some women in this occupational group are known to periodically engage in transactional and commercial sex to supplement their income and are therefore considered to be at increased risk of HIV and sexually transmitted infections, and to represent a potential study population for future microbicide and other HIV prevention trials.

This thesis describes the development of separate assays to measure coenzyme Q₁₀ (CoQ₁₀) and vitamin K. Coenzyme Q is essential for the mitochondrial electron transport chain, and vitamin K for the blood coagulation cascade. Vitamin K deficiency is associated with haemorrhagic disease of the new-born, and CoQ₁₀ deficiency with HMG-CoA-reductase inhibitor (statin) therapy and heart failure. Coenzyme Q and vitamin K are usually measured by HPLC, using electrochemical and ultraviolet, and electrochemical and fluorescence detection, respectively. For vitamin K1, the limit of detection achieved using fluorescence and electrochemical detection was 0.28 and 0.12 nmol/L, respectively. Sensitivity of fluorescence detection is improved by using protic solvents in the mobile phase, and platinum-black catalysed alcohol reduction. The lipophilicity and low endogenous concentrations of vitamin K1 hinder its measurement, and further work is required to produce a rapid, reliable and robust assay for its measurement in human plasma. The limits of detection achieved using fluorescence, ultraviolet and electrochemical detection to measure CoQ₁₀ were 29, 4.8, and 0.34 nmol/L, respectively. Plasma CoQ₁₀ is not stable during long term storage at -13 ℃, but at -80 ℃ it is stable for at least 18 months. The reference interval for plasma total CoQ₁₀ in the New Zealand population is 0.47 - 1.80 µmol/L. There is no clinical requirement for stratification of the reference interval according to gender. Coenzyme Q₁₀ in human plasma is homeostatically controlled, varying little over a two month interval in healthy young males. Coenzyme Q₁₀ supplements have significantly different bioavailability, with the median increase in plasma CoQ₁₀ ranging from 0.14 to 0.59 µmol/L for seven different supplement brands. There is a large inter-individual variation in CoQ₁₀ absorption, and hence plasma concentrations should be monitored during supplementation. A plateau in CoQ₁₀ absorption, from a single dose, at approximately 200 mg suggests that the maximum dose ingested at one time should be 200 mg or less. Q-Gel capsules containing 30 mg of CoQ₁₀ are twice as effective at raising blood CoQ₁₀ as 100 mg capsules. Plasma CoQ₁₀ in patients with chronic heart failure are significantly lowered by approximately 33% when these patients receive Atorvastatin for six weeks. The absolute decrease in CoQ₁₀ showed a significant correlation with worsening endothelial function (r = + 0.548, p = 0.011). Coenzyme Q₉ was shown to be present in human plasma with a reference interval of 8.8 - 47.0 nmol/L.

Orientador: Luciana Patrícia Fernandes Abbade / Resumo: Introdução: A biomembrana produzida com celulose é usada como pele substituta temporária no tratamento de úlceras de difícil cicatrização. Esse estudo avaliou a eficácia e segurança da biomembrana de celulose comparada ao curativo com colagenase para a redução de área de úlceras venosas, durante um período de 90 dias. Método: ensaio clínico controlado, randomizado e aberto com dois grupos de tratamento paralelos - grupo biomembrana de celulose e grupo colagenase – em participantes com úlcera venosa. Os dois grupos receberam terapia compressiva. O desfecho primário foi redução da área da úlcera (em centímetros quadrados) depois de 90 dias de tratamento (T90). Os desfechos secundários foram cicatrização, redução de tecidos desvitalizados, redução de exsudato, angiogênese, mudanças na qualidade de vida e segurança. A análise estatística foi por intenção de tratar e os dados foram analisados utilizando o software SPSS 20.0. Foi considerado significante p<0,05. Resultados: Foram randomizados 46 participantes com 73 úlceras venosas, 21 participantes com 36 úlceras no grupo colagenase e 25 participantes com 37 úlceras no grupo biomembrana. Houve uma redução de área da úlcera no T90 nos dois grupos, sem diferença estatística entre as duas intervenções (p=0,66). Cicatrização completa no T90 ocorreu em sete úlceras no grupo colagenase e 12 úlceras no grupo biomembrana, sem diferença significante (p= 0,20); contudo, a biomembrana promoveu uma maior proporção de cicatrização precoce (p=0... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: Background: A biomembrane produced from cellulose is used as temporary replacement skin in the treatment of ulcers with healing difficulties. This study assessed the efficacy and safety of cellulose biomembrane compared to those of a collagenase dressing in decreasing venous ulcer area during a 90 day period. Methods: controlled, randomized and open clinical trial with two parallel treatment groups - a cellulose biomembrane group and a collagenase group - in participants with venous ulcer. Both groups received compression therapy. The primary outcome was a reduction in ulcer area (square centimeters) after 90 days of treatment (T90). Secondary outcomes were healing status, devitalized tissue reduction, exudate reduction, angiogenesis, quality of life change and safety. The statistical analysis was of intention to treat, and data were analyzed using the software SPSS 20.0. A p<0.05 value was considered significant. Results: We randomized 46 participants with 73 venous ulcers and 21 participants with 36 ulcers in the collagenase group and 25 participants with 37 ulcers in the biomembrane group. There was an ulcer area reduction at T90 in both groups, but the difference was not significant (p=0.66). Complete healing prior to T90 occurred in seven ulcers in the collagenase group and 12 ulcers in the biomembrane group, without a significant difference (p= 0.20); however, the biomembrane promoted a greater proportion of precocious healing (p=0.02). There was improved bed vitality a... (Complete abstract click electronic access below) / Doutor

abstract: An ever expanding body of research has shown that children of divorce are at increased risk for a range of maladaptive outcomes including academic failure, behavior problems, poor psychological adjustment, reduced self-concept, and reduced social competence (Amato, 2001). Furthermore, the widespread prevalence of divorce makes preventing these poor outcomes a pressing public health concern. The Children of Divorce-Coping with Divorce (CoD-CoD) program is an internet-based selective prevention that was derived from recent research identifying modifiable protective factors in children of divorce including active and avoidant coping, divorce appraisals, and coping efficacy. CoD-CoD addresses these putative mediators through careful adaptation of intervention components previously demonstrated to be effective for children from disrupted families (Pedro-Carroll & Alpert-Gillis, 1997; Stolberg & Mahler, 1994; Sandler, et al., 2003). In the CoD-CoD efficacy trial, 147 children ages 11-16 whose family had received a divorce decree within 48 months of the intervention start date served as participants. Participants were assessed in two waves in order to test the small theory of the intervention as well as the interventions effects on internalizing and externalizing behaviors. Analyses indicated that the program effectively reduced the participants total mental health problems and emotional problems as reported on the Strengths and Difficulties Questionnaire (SDQ) (d = .37) and for total mental health problems this effect was stronger for children with greater baseline mental health problems (d = .46). The program also had mediated effects on both child and parent-reported total mental health problems whereby the program improved coping efficacy for children with low baseline coping efficacy which led to reduced parent-reported mental health problems. To the author's knowledge this is the first randomized controlled trail of internet-based mental health program for children or adolescents which utilizes an active control condition. / Dissertation/Thesis / Ph.D. Psychology 2011

El texto completo de este trabajo no está disponible en el Repositorio Académico UPC por restricciones de la casa editorial donde ha sido publicado. / Background: Clinical trial completion is critical for new cancer therapies. Premature trial termination or withdrawal is common and impairs progress. We assessed factors of early terminated/withdrawn oncology trials focusing on trials with immune checkpoint inhibitors (ICI), hypothesizing that the latter may be associated with lower rates of premature discontinuation. Materials and Methods: We reviewed all adult, intervention, oncology trials registered in ClinicalTrials.gov (November 16, 2011, to April 16, 2015) to identify all terminated/withdrawn trials and reasons for termination. Logistics regression model was used to identify factors associated with early termination/withdrawal. Discontinuation rate was compared in trials with and without ICI. Results: We identified 12,875 trials (35% industry funded, 12% federal funded), of which 8.5% were prematurely terminated (5%) or withdrawn (3.5%); the main reasons were poor accrual (33%) and logistical (24%). ICI trials (n = 350) had a nonsignificant lower rate of termination or withdrawal compared with all other oncology trials (5.4% vs. 8.5%; p =.9) and were less likely to discontinue due to poor accrual (nonsignificant difference: 21% vs. 33%; p =.4). ICI trials were also less likely to discontinue compared with all other oncology drug trials (e.g., chemotherapy, targeted inhibitors, antiangiogenesis, biologics; 5.4% vs. 7.9%, respectively, nonsignificant difference). The 4-year cumulative incidence of failing to complete for reasons unrelated to toxicity or efficacy was 18% (95% confidence interval 16%–20%). There was no association between annual incidence across different tumor types or accrual goal and rate of trial termination. Conclusion: Poor accrual represents the main cause of early cancer trial termination. Premature termination/withdrawal rate was not significantly lower in ICI compared with other trials. Clinical trial completion remains a high priority and can be influenced by provider and patient factors. Implications for Practice: Clinical trial completion is critical for new cancer therapies. Premature trial termination or withdrawal is common and impairs progress. This study assessed factors of early terminated/withdrawn oncology trials, focusing on trials with immune checkpoint inhibitors (ICI), and found that poor accrual represents the main cause of early cancer trial termination. Premature termination/withdrawal rate was not significantly lower in immune checkpoint inhibitor trials compared to other trials. The discussion herein is focused on measures taken by the National Cancer Institute and other institutions to improve clinical trial accrual and prevent premature clinical trial discontinuation. / Revisión por pares

OBJECTIVE: The aim of this study was to investigate the safety and tolerability of a novel anti-folate drug, pemetrexed, in the setting of a phase I clinical trial in patients with non-HIV related central nervous system lymphoma (CNSL). METHODS: In this multicenter, open-label, phase I dose finding clinical trial, pemetrexed was investigated as a single agent treatment for primary or secondary CNSL. RESULTS: A total of 18 patients were enrolled between January 2009 and November 2014. The mean age was 64.6 years old (range: 47-79). The ratio of male to female was 1:1. One out of six patients experienced a dose limiting toxicity (DLT) at dose level 1 (600mg/m2). There were no DLTs among the four patients enrolled at dose level 2 (900m/m2). Two of six patients experienced a DLT at dose level 3 (1200mg/m2). The MTD was therefore determined to be 900mg/m2. Overall, pemetrexed was well tolerated but toxicities were seen and need to be monitored. All patients experienced at least one type of toxicity of any grade. Most patients (92.9%) experienced at least one type of neurological toxicity. Grade-3 toxicities included confusion, speech impairment, and psychosis. Twelve patients (85.7%) experienced at least one bone marrow type of toxicity of any grade. These toxicities included anemia (78.6%), thrombocytopenia (57.1%), neutropenia (50%), leukocytopenia (42.9%), and lymphopenia (42.9%). Four patients experienced either grade-3 (14.3%) or grade-4 (14.3%) neutropenia. Three patients experienced grade-3 leukopenia (21.4%). One patient experienced grade-3 lymphopenia (7.1%) and two patients experienced grade-4 lymphopenia (14.3%). Twelve patients (85.7%) experienced at least one metabolic type of toxicity of any grade. A majority of these were also grade-1 or 2, with the exception of hypophosphatemia (grade-4), hyperglycemia (grade-3) and increased ALT (grade-3), increased AST (grade-3) and increased creatinine phosphokinase (CPK) (grade-4). Constitutional and gastrointestinal symptoms were seen in >60% of patients. These consisted mainly of fatigue, constipation, nausea, and anorexia. Musculoskeletal symptoms were seen in greater than 60% of patients. Less common adverse events included pain (<60%), infection (<40%), dermatologic, ocular/visual, and pulmonary/upper respiratory (<30%). The average number of cycles on treatment for all patients was 5.5 cycles. 14 patients were evaluated for response to treatment by neuroimaging (MRI) while on treatment. Of these, four patients (28.6%) showed a complete response (CR). Of those patients, 2 patients achieved this response after only 2 doses, and 2 patients after a total of 8 doses. 5 patients (35.7%) showed a partial response (PR) and four patients (28.6%) achieved stable disease (SD). The overall response rate (ORR) was determined at 92.9% (SD, PR and CR combined). CONCLUSIONS: Given this data, pemetrexed is a powerful drug and feasible alternative to existing treatment options; however, certain toxicities need to be closely monitored. Further studies are needed to assess the efficacy of pemetrexed in a larger cohort of patients with CNSL.

O uso do infiltrante resinoso tem sido apontado como uma abordagem promissora para preencher a lacuna entre o tratamento não-invasivo e o tratamento invasivo em lesões proximais não-cavitadas (LPNC). No entanto, estudos clínicos não são conclusivos sobre o efeito deste tratamento na redução da progressão dessas lesões uma vez que foram realizados em indivíduos cuja atividade cárie não foi controlada. Desta forma, este estudo teve por objetivo avaliar a eficácia do uso do infiltrante resinoso em LPNC na redução da progresão dessas lesões ao longo de um período de 3 anos em um grupo de indivíduos que receberam tratamento e controle da doença cárie. Vinte e dois indivíduos cárie-ativos que possuíam pelo menos um par de LPNC em dentes posteriores foram selecionados para este estudo, totalizando 36 pares de lesões radiograficamente classificadas de metade externa de esmalte até junção amelo-dentinária. Em um delineamento do tipo boca-dividida, as lesões foram alocadas aleatoriamente para tratamento teste (uso do infiltrante resinoso – ICON, DMG, Hamburg, Germany) ou tratamento placebo, de forma que cada par de lesões recebeu os dois tratamentos. Após 3 anos, essas lesões foram novamente analisadas e sua progressão registrada radiograficamente pela análise pareada das radiografias iniciais com as radiografias após 3 anos. Índice de sangramento gengival (ISG) e atividade de cárie foram avaliados no início do estudo e aos 3 anos de acompanhamento. Diferenças na progressão de lesões entre as superfícies infiltradas e aquelas que receberam tratamento placebo foram comparadas pelo teste de McNemar. Dezessete individuos (27 pares de lesões) foram re-avaliados após 3 anos (drop-out de 22,7%). Não foi encontrada diferença no ISG dos indivíduos na comparação entre o início do estudo e aos 3 anos de acompanhamento. No entanto, três vezes menos sangramento gengival foi observado nas superfícies proximais de interesse (que receberam o infiltrante ou o tratamento placebo). Somente 4 indivíduos apresentaram atividade de cárie aos 3 anos. Em relação à progressão das lesões, 7,4% das lesões infiltradas (2/27) progrediram, enquanto que 18,5% das lesões que receberam tratamento placebo (5/27) apresentaram progressão, não havendo diferença estatística entre os grupos (p=0,453). Os resultados do presente estudo sugerem que nenhum efeito adicional na redução da progressão de LPNC foi encontrado após o uso de infiltrante resinoso em comparação a grupo placebo uma vez que a atividade de cárie é controlada ao nível individual. / Resin infiltration technique of carious lesion has been claimed as a promising approach to fill the gap between non-invasive and operative treatment on the management of non-cavitated proximal lesions (NCPL). However, clinical studies are inconclusive about the effect of this treatment on the reduction NCPL progression since they were performed in a group of subjects whose caries activity was not controlled. Therefore, this study aimed to assess the efficacy of resin infiltration of NCPL over a 3-year period in a group of individuals who received treatment and control of carious activity in order to better clarify the role of lesion infiltration on the management of NCPL. Twenty-two caries-active subjects that possessed at least a pair of NCPL in posterior teeth were selected for this study totalizing 36 pairs of lesion radiographically classified from outer half of enamel to enamel-dentin junction. In a split-mouth design, lesions were randomly allocated to test treatment (resin infiltration) or placebo treatment. At 3-year follow-up, the studied lesions were radiographically analyzed and the radiolucency progression registered. Lesion progression was then determined by pair-wise comparison. Gingival bleeding index (GBI) was also assessed at the beginning of the study and at the follow-up. Lesion activity was determined at 3 years follow-up. Differences in number of progressing lesions between test and placebo- treated surfaces were compared using McNemar test. Seven-teen subjects (27 pairs of lesions) were followed-up (drop-out rate of 22.7%). No difference was found on subject’s median GBI between the baseline and at its follow-up. However, 3 times less gingival bleeding of test and placebo-treated proximal surfaces was observed at the follow-up. Only 4 subjects were caries active at the follow-up. In the test group, 2/27 (7.4%) lesions and in the placebo group 5/27 (18.5%) lesions had progressed. No statistical difference was observed between the studied groups (p=0.453). The results of the present study suggest no additional effect of resin infiltration on the reduction of lesion progression when compared with placebo-treated lesions once caries activity is controlled at an individual level.

Objetivos: O objetivo deste ensaio clínico randomizado foi avaliar o comportamento de restaurações de resina composta bulk-fill em dentes posteriores (classes I e II). Metodologia: Dezessete pacientes que necessitavam de restaurações em pelo menos dois dentes posteriores foram selecionados para participar do estudo. As causas para indicação das restaurações foram: substituição de restauração deficiente de amálgama ou resina composta e/ou lesão de cárie. Em cada paciente foram realizadas duas restaurações. Randomicamente, uma cavidade foi restaurada com a resina nanohíbrida Esthet-X HD (grupo controle) e a outra restaurada com a resina Esthet-X HD associada à resina de baixa contração Surefil SDR Flow (grupo teste). Em ambos os grupos, um sistema adesivo convencional de dois passos (XP Bond) foi utilizado. Todos os pacientes receberam tratamento global para a atividade cariosa. Após um período de quatro anos, a qualidade das restaurações foi avaliada por 1 examinador previamente calibrado, através de uma modificação do método USPHS e através do método FDI. Os dados obtidos foram submetidos à análise estatística pelo teste não-paramétrico Mann-Whitney (p<0,05) e a concordância intra-observador avaliada através de teste Kappa. Resultados: No quarto ano de acompanhamento, 26 dentes (18 restaurações classe I e 8 classe II) foram avaliadas, e não foram observadas diferenças estatisticamente significantes entre as restaurações dos grupos controle e teste para os métodos de avaliação utilizados. Não houve falhas em nenhuma das restaurações ao longo do tempo. Conclusão: A qualidade das restaurações classe I e II com resina bulk-fill foi semelhante à das restaurações com resina nanohíbrida convencional. A técnica com resina bulk-fill mostrou bom desempenho clínico tão bom quanto a convencional durante os 4 anos de acompanhamento. / Objectives: The objective of this randomized clinical trial was to evaluate the behavior of bulk-fill composite restorations in posterior teeth (classes I and II). Methodology: Seventeen patients who required restorations on at least two posterior teeth were selected to participate in the study. The causes for indication of restorations were: replacement of deficient amalgam or composite resin restoration and/or caries lesion. In each patient, two restorations were performed. Randomly, one cavity was restored with Esthet-X HD nanohybrid composite (control group) and the other was restored with Esthet-X HD resin associated with the bulk-fill composite Surefil SDR Flow (test group). In both groups, a two-step total-etch adhesive system (XP Bond) was used. All patients received global treatment for carious activity. After a period of four years, the quality of the restorations was evaluated by a previously calibrated examiner, through a modification of the USPHS method and through the FDI method. The data were submitted to statistical analysis by the non-parametric Mann-Whitney test (p <0.05) and the intra-observer agreement was evaluated by Kappa test. Results: At the 4-year follow-up, 26 teeth (18 class I and 8 class II restorations) were evaluated, and no statistically significant differences between control and test groups were observed for both evaluation methods used. There were no failures in any of the restorations over time. Conclusion: The quality of class I and II restorations with bulk-fill resin was similar to that of conventional nanohybrid resin. The bulk-fill composite technique showed good clinical performance as well as the conventional one during the 4 years of follow-up.

Submitted by Raquel Colenci null (raquelcolenci@fmb.unesp.br) on 2018-02-07T01:05:02Z No. of bitstreams: 1 Biomembrana de celulose versus curativo com colagenase no tratamento de úlceras venosas crônicas ensaio clínico randomizado, aberto e controlado.pdf: 2086004 bytes, checksum: 5011bc7aa0b1aeb96375f91e925039b2 (MD5) / Approved for entry into archive by ROSANGELA APARECIDA LOBO null (rosangelalobo@btu.unesp.br) on 2018-02-08T10:57:04Z (GMT) No. of bitstreams: 1 colenci_r_dr_bot.pdf: 2086004 bytes, checksum: 5011bc7aa0b1aeb96375f91e925039b2 (MD5) / Made available in DSpace on 2018-02-08T10:57:04Z (GMT). No. of bitstreams: 1 colenci_r_dr_bot.pdf: 2086004 bytes, checksum: 5011bc7aa0b1aeb96375f91e925039b2 (MD5) Previous issue date: 2017-12-11 / Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) / Introdução: A biomembrana produzida com celulose é usada como pele substituta temporária no tratamento de úlceras de difícil cicatrização. Esse estudo avaliou a eficácia e segurança da biomembrana de celulose comparada ao curativo com colagenase para a redução de área de úlceras venosas, durante um período de 90 dias. Método: ensaio clínico controlado, randomizado e aberto com dois grupos de tratamento paralelos - grupo biomembrana de celulose e grupo colagenase – em participantes com úlcera venosa. Os dois grupos receberam terapia compressiva. O desfecho primário foi redução da área da úlcera (em centímetros quadrados) depois de 90 dias de tratamento (T90). Os desfechos secundários foram cicatrização, redução de tecidos desvitalizados, redução de exsudato, angiogênese, mudanças na qualidade de vida e segurança. A análise estatística foi por intenção de tratar e os dados foram analisados utilizando o software SPSS 20.0. Foi considerado significante p<0,05. Resultados: Foram randomizados 46 participantes com 73 úlceras venosas, 21 participantes com 36 úlceras no grupo colagenase e 25 participantes com 37 úlceras no grupo biomembrana. Houve uma redução de área da úlcera no T90 nos dois grupos, sem diferença estatística entre as duas intervenções (p=0,66). Cicatrização completa no T90 ocorreu em sete úlceras no grupo colagenase e 12 úlceras no grupo biomembrana, sem diferença significante (p= 0,20); contudo, a biomembrana promoveu uma maior proporção de cicatrização precoce (p=0,02). Houve melhora na vitalidade do leito e na qualidade de vida em função do tempo (p<0,01), porém sem diferença significante entre os grupos. A análise do marcador CD34 mostrou que a fração vascular aumentou nos dois grupos (p<0,01); contudo, o nível foi maior no grupo biomembrana (p<0,05). Os eventos adversos não foram considerados relacionados aos produtos. Conclusões: A biomembrana de celulose é efetiva e segura no tratamento de úlceras venosas associada à terapia compressiva, com resultados similares aos do tratamento com colagenase. Por ser unicêntrico, foi difícil a inclusão de maior número de participantes e os resultados precisam ser confirmados por ensaios clínicos com maior tamanho amostral e multicêntricos. Não foi possível realizar cegamento dos participantes e do pesquisador devido ao aspecto diferente dos dois tipos de curativos. / Background: A biomembrane produced from cellulose is used as temporary replacement skin in the treatment of ulcers with healing difficulties. This study assessed the efficacy and safety of cellulose biomembrane compared to those of a collagenase dressing in decreasing venous ulcer area during a 90 day period. Methods: controlled, randomized and open clinical trial with two parallel treatment groups - a cellulose biomembrane group and a collagenase group - in participants with venous ulcer. Both groups received compression therapy. The primary outcome was a reduction in ulcer area (square centimeters) after 90 days of treatment (T90). Secondary outcomes were healing status, devitalized tissue reduction, exudate reduction, angiogenesis, quality of life change and safety. The statistical analysis was of intention to treat, and data were analyzed using the software SPSS 20.0. A p<0.05 value was considered significant. Results: We randomized 46 participants with 73 venous ulcers and 21 participants with 36 ulcers in the collagenase group and 25 participants with 37 ulcers in the biomembrane group. There was an ulcer area reduction at T90 in both groups, but the difference was not significant (p=0.66). Complete healing prior to T90 occurred in seven ulcers in the collagenase group and 12 ulcers in the biomembrane group, without a significant difference (p= 0.20); however, the biomembrane promoted a greater proportion of precocious healing (p=0.02). There was improved bed vitality and quality of life as a function of time (p<0.01), but there was no significant difference between the groups. The marker CD34 analysis showed that the vascular fraction increased in both groups (p<0.01); however, the level was higher in the biomembrane group (p<0.05). No adverse events were considered related to the products. Conclusions: Cellulose biomembrane is effective and safe in the treatment of venous ulcers associated with compressive therapy, with similar results to those of collagenase treatment. Because it was unicentric, it was difficult to include a larger number of participants and the results need to be confirmed by clinical trials with larger sample size and multicentric. It was not possible to blind the participants and the researcher due to the different aspect of the two types of dressings / 2014/05533-0