Will applications on smartphones allow a generalization of telemedicine?

BACKGROUND: Telemedicine is one of the healthcare sectors that has developed the most in recent years. Currently, telemedicine is mostly used for patients who have difficulty attending medical consultations because of where they live (teleconsultation) or for specialist referrals when no specialist of a given discipline is locally available (telexpertise). However, the use of specific equipment (with dedicated cameras, screens, and computers) and the need for institutional infrastructure made the deployment and use of these systems expensive and rigid. Although many telemedicine systems have been tested, most have not generally gone beyond local projects. Our hypothesis is that the use of smartphones will allow health care providers to overcome some of the limitations that we have exposed, thus allowing the generalization of telemedicine. MAIN BODY: This paper addresses the problem of telemedicine applications, the market of which is growing fast. Their development may completely transform the organization of healthcare systems, change the way patients are managed and revolutionize prevention. This new organization should facilitate the lives of both patients and doctors. In this paper, we examine why telemedicine has failed for years to take its rightful place in many European healthcare systems although there was a real need. By developing the example of France, this article analyses the reasons most commonly put forth: the administrative and legal difficulties, and the lack of funding. We argue that the real reason telemedicine struggled to find its place was because the technology was not close enough to the patient. CONCLUSION: Finally, we explain how the development of smartphones and their current ubiquitousness should allow the generalization of telemedicine in France and on a global scale.

[Prevalence of asymmetrical blood pressure in uncontrolled hypertensive patients is high and highly related with cardiovascular diseases prevalence]. / La prévalence de l'asymétrie tensionnelle chez les patients hypertendus non contrôlés est importante et fortement associée aux comorbidités cliniques et infracliniques.

A meta-analysis has shown that an asymmetry of the blood pressure (ABP) between arm≥15mmHg and perhaps≥10mmHg is associated with an increase of cardiovascular diseases. To describe the prevalence of ABP in patients presenting an uncontrolled blood pressure (BP) under treatment, an observational cross sectional study was conducted. Factors influencing prevalence of ABP were identified and relation of ABP with the frequency of the cardiovascular diseases or subclinicals organs damages was evaluated. A total of 2417 patients, 63.3±11.0years old, presenting uncontrolled BP (according ESC criteria) by a previous antihypertensive therapy were included. Only 36.8% (95% CI [34.9-38.7]) were presenting a between-arm difference in systolic blood pressure≥10mmHg, and 17.1% (95% CI [15.6-18.6])≥15mmHg. MRA shows systolic ABP≥10mmHg prevalence was influenced by dyslipidemia (OR: 1.5 [1.2-1.7], P<0.0001) and by family history of early cardiovascular disease (OR: 1.6 [1.3-1.9], P<0.0001). MRA adjusted on CVRF shows that besides the dyslipidemia effect, systolic ABP≥10mmHg influences the frequency of sub-clinical impairment of target organ (OR: 1.6 [1.3-1.9], P<0.0001), of coronary heart disease (OR: 1.8 [1.4-2.4], P<0.0001), and globally the presence of a cardiovascular disease (OR: 1.7 [1.4-2.1], P<0.0001). The effect on stroke frequency was showed with an systolic ABP≥15mmHg (OR: 1.6 [1.1-2.4], P<0.02). In uncontrolled hypertensive patients, screening of an ABP should help to identify clinically patients with high risk of cardiovascular diseases or with subclinical organs damages.

Evaluation of adherence by elderly nursing home patients to regular consumption of apple compote enriched with protein and soluble fiber.

BACKGROUND: An increase in daily doses of protein and fiber for the elderly is relevant in preventing sarcopenia and preserving intestinal balance. However, such intake of supplements is often compromised by the lack of adherence among the elderly. OBJECTIVES: The main objective was to evaluate the perception of the hedonic qualities of compote enriched with NUTRALYS(®) pea protein, NUTRALYS(®)W hydrolyzed wheat gluten and NUTRIOSE(®) soluble fiber and the changes in that perception due to repeated consumption. The secondary objectives were to evaluate the evolution in the quantity of compote eaten, satisfaction with consumption and any changes in fatigue, digestive comfort and digestive tolerance when eating compote every other day for 3 weeks. METHOD: An observational study was conducted in nursing homes on volunteers aged 70-90 years. The compote was proposed as a lunchtime dessert every two days for a period of three consecutive weeks. All criteria were evaluated at days D0 and/or D1, D7, D15 and D21, except for the amount of compote eaten, evaluated after each meal at which it was served. RESULTS: When first tasted, the compote was judged 'rather pleasant' to 'very pleasant' by 91.6 % and this rating held up at 79.2 % (p = 0.1797) after 1 week, 83.3 % (p = 0.3173) after 2 weeks and 79.2 % (p = 0.2568) after 3 weeks. Average consumption of compote was stable and varied between a maximum of 79.5 % of the total quantity at inclusion to a minimum of 61.5 % recorded on D17. The other parameters did not change significantly. CONCLUSION: Pea protein, hydrolyzed wheat gluten and soluble fiber seem to provide an appropriate form of protein and fiber supplementation in the diets of elderly people in nursing homes.

How French subjects describe well-being from food and eating habits? Development, item reduction and scoring definition of the Well-Being related to Food Questionnaire (Well-BFQ©).

Providing well-being and maintaining good health are main objectives subjects seek from diet. This manuscript describes the development and preliminary validation of an instrument assessing well-being associated with food and eating habits in a general healthy population. Qualitative data from 12 groups of discussion (102 subjects) conducted with healthy subjects were used to develop the core of the Well-being related to Food Questionnaire (Well-BFQ). Twelve other groups of discussion with subjects with joint (n = 34), digestive (n = 32) or repetitive infection complaints (n = 30) were performed to develop items specific to these complaints. Five main themes emerged from the discussions and formed the modular backbone of the questionnaire: "Grocery shopping", "Cooking", "Dining places", "Commensality", "Eating and drinking". Each module has a common structure: items about subject's food behavior and items about immediate and short-term benefits. An additional theme - "Eating habits and health" - assesses subjects' beliefs about expected benefits of food and eating habits on health, disease prevention and protection, and quality of ageing. A preliminary validation was conducted with 444 subjects with balanced diet; non-balanced diet; and standard diet. The structure of the questionnaire was further determined using principal component analyses exploratory factor analyses, with confirmation of the sub-sections food behaviors, immediate benefits (pleasure, security, relaxation), direct short-term benefits (digestion and satiety, energy and psychology), and deferred long-term benefits (eating habits and health). Thirty-three subscales and 14 single items were further defined. Confirmatory analyses confirmed the structure, with overall moderate to excellent convergent and divergent validity and internal consistency reliability. The Well-BFQ is a unique, modular tool that comprehensively assesses the full picture of well-being related to food and eating habits in the general population.

Cross-sectional study on heredity and venous disorders: the end of the dominant maternal heredity dogma?

OBJECTIVE: To evaluate the heredity factor of the chronic venous disorders and odds ratio linked to maternal or paternal heredity. METHODS: Cross-sectional epidemiological study conducted in daily practice of medical practitioners on all patients consulting them. The practitioners described the venous status of all patients consulting them and recorded the familial past history of venous disease. RESULTS: Among 21319 patients, 60.4% have a familial history of chronic venous disorder: unilateral paternal 7.5%, unilateral maternal 40.9% and bilateral: 12.0%. Chronic venous disorder prevalence is 58.8% in the global population, 38.2% in the absence of parental history, 67.0% for unilateral paternal, 71.3% for unilateral maternal and 79.2% for bilateral (p < 0.0001). After adjustment on age and sex, results show significant (p < 0.0001) odds ratio of 3.2 for unilateral paternal, of 3.4 for unilateral maternal and of 5.6 for a history in both parents. In the context of a history in both parents, the odds ratio increased to 5.6 for women and 8.4 for men. CONCLUSION: This large cross-sectional study confirms the association between heredity and venous disease, but its results could call into question the maternal predominant character of the chronic venous disorder heredity.

Observational study of the effect of substituting NaCl with NaCl+Chitosan 3% (Symbiosal®) in the diet of elderly subjects on their blood pressure values.

AIM: The main objective of the study was to describe changes in the blood pressure (BP) values of a cohort of elderly subjects as a result of substituting NaCl with NaCl+Chitosan 3% (Symbiosal®) in their diet (salt used during food preparation and added table salt). METHODS: An observational study was conducted in a rehabilitation centre for elderly where all cooked foods are produced by the local kitchen and all the salt NaCl traditionally used was replaced by Symbiosal®. All patients, hypertensive or not, were followed at inclusion and then every month to monitor their BP parameters over three months. RESULTS: In the total population of seventy-seven patients, SBP (mmHg) decreases from 130±17 at inclusion to 123±10 at 3 months (-7.8±8.5) (P<0.0001). In sixteen persons, whose hypertension was not under control at inclusion, it decreases from 156±18 to 136±12 after 3 months (-19.6±7.3) (P<0.0001) and among them 68.5% were controlled. In the subject with limit hypertension (between 130-140) it decreases from 135.7±3.1 to 123.2±4.9 (-12.5±4.6) (P<0.0001). CONCLUSION: NaCl + chitosan 3% seems to reduce significantly the BP. This suggests that it could be used either in the field of a low salt diet in hypertensive patients but also in general or elderly population in addition to the recommendation of a salt reduction.

How to sensitize patients to their venous disease? A new tool: the venous age calculator.

The venous age is a calculation tool inspired by the arterial age of the Framingham study whose purpose is to sensitize people to their venous conditions and the need of taking care of it. It indicates a person's venous age according to their gender and to the functional signs and physical symptoms they are presenting. The calculation results from the analysis of a worldwide data base including 124,235 people from 24 countries, having or not a venous insufficiency, and whose functional or physical symptoms are described in this study.

Thermal ablation of saphenous veins is feasible and safe in patients older than 75 years: A prospective study (EVTA study).

OBJECTIVES: To investigate the tolerance and safety of thermal ablation (TA), consisting of radiofrequency or endovenous laser (EVLA) of saphenous veins (SV) in elderly (group 1 ≥75 years), compared with a control group (group 2 <75 years). METHOD: An Observational multicenter-prospective study was conducted, under the aegis of the French and Swiss Societies of Phlebology (18 centers). Ninety patients were included in group 1, 617 in group 2 (mean age 80 years and 53 years; 69% women in both groups), representing 863 SV. Mean trunk diameters were similar in both groups (small SV: 6 mm; great SV: 7 mm). In group 1, comorbidities were more frequent, particularly cardiac insufficiency, diabetes, history of thrombosis, and CEAP clinical class was significantly higher. RESULTS: EVLA was used in 86% of cases. Settings used were similar in both groups for each technique. Only 6% of TA was performed in an operating room for group 1 (14% group 2). Tumescent local anaesthesia (TLA) alone was used in 91% of cases in group 1 (85% group 2). The mean pain score was only 1.6 for the procedure itself (VASP 0-10; 10 max.) and 1.4 for the 10 days following the procedure. Side effects were few, but rate of paraesthesia was higher when general anaesthesia was used (11.8%) compared with TLA alone (2.2%). At three months, 100% of SV was occluded in group 1 (99.5% group 2), with high satisfaction score (9.3/10). CONCLUSION: TA is safe and effective in elderly; it should be performed strictly under TLA to minimize side effects.

Secure Teleassistance towards endless medical litigations: identification of liabilities through a protocol using Joint Watermarking-Encryption Evidences.

Teleassistance is defined by the help provided through a telemedicine network by a medical practitioner to one other medical practitioner faced to a difficult case. One of the main limiting factors of its development is the fear of the practitioners to be involved in a litigation. In such a situation, the main issue is to determine as quick and as certain as possible if the damage is in relation with the tort of negligence and the liabilities of each involved physician. After a brief summary of the legal context, we present a protocol combining joint watermarking-encryption and a third party to enforce exchange traceability and therefore to bring valuable electronic evidence in case of teleassistance litigations.

[Evolution of lower urinary tract symptoms under silodosin: factors influencing patients' satisfaction]. / Évolution des symptômes du bas appareil urinaire sous silodosine: facteurs influençant la satisfaction des patients.

UNLABELLED: The objective of this study was to analyze the efficacy and safety of silodosin in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in current urologic practice. METHOD: This was a prospective observational study conducted by 272 urologists on patients treated by silodosin for BPH. The parameters evaluated were the weighted IPSS score, the IPSS question 8 related to quality of life, the USP score and the Athens Insomnia Scale (AIS) measured at treatment initiation and after 3 months. RESULTS: Nine hundred and fourteen patients whose average age was 66 years with LUTS for 3.3 years were analyzed. After 3 months of treatment, a significant decrease in IPSS (from 16.2 ± 6.1 to 9.7 ± 5.5, P<0.0001) and USP score (from 10.6 ± 5.1 to 6 0 ± 4.6, P<0.0001) were observed, quality of life (from 67.1% to 14.4% of unsatisfied patients, P<0.0001) and sleep were significantly improved (from 49.2% to 28.9% patients with insomnia, P<0.0001). Among the patients, 21.2% experienced at least one adverse event. The most frequent were abnormal ejaculation (17.2%). And 7.1% discontinued the treatment for this reason. After 3 months of treatment silodosin was continued in 86.9% of patients. CONCLUSION: This large study confirmed the efficacy of silodosin in LUTS associated with BPH with a safety profile that does not affect patient satisfaction.

Dietary supplementation contributes to lifestyle improvement in hypercholesterolemic patients in real-life contexts.

AIMS: Assess the evolution of cardiovascular lifestyle behaviors in hypercholesterolemic patients concomitantly with changes in their daily intake of phytosterol-supplemented yoghurt (Phyto-SY). METHODS: Nationwide prospective observational study conducted in general practices across France and Spain. Each practitioner suggested lifestyle changes to five consecutive patients with hypercholesterolemia (whether or not they were taking hypocholesterolemic drugs) and recommended daily consumption of Phyto-SY. The study design involved an inclusion visit, a patient's self-monitoring assessment after 1 month, and a final visit after 4 months. Primary evaluation criterion: changes in dietary habits assessed by a standardized Nutritional Lifestyle score. Secondary criteria: changes in lipid profile, anthropometry (waist circumference) and lifestyle behavior. RESULTS: A total of 2376 hypercholesterolemic patients (of whom 54.8% were women) were included. The average age was 56.2 years old. The Nutritional Lifestyle score improved from 15.4 ± 5.4 to 8.7 ± 4.0 (p < 0.0001). Total cholesterol decreased by 10.6% (<0.0001), HDL-C increased by 8.0% (<0.0001), and LDL-C fell by 12.7% (<0.0001). Similar results were observed in patients treated with statins and those who were not. Frequency of walking (>30 min) increased from 59.3% to 78.3% (p < 0.0001). The overweight rate decreased from 22.8% to 17.5% (p < 0.0001) and waist circumference from 94.6 ± 13.3 cm to 93.0 ± 12.8 cm (p < 0.0001). Nutritional Lifestyles and other lifestyle markers' improvement were parallel to adherence to Phyto-SY adherence. CONCLUSION: Improvements in Nutritional Lifestyle scores, which included regular consumption of Phyto-SY over 4 months, was significantly linked to healthier lifestyles and to beneficial modifications in atherogenic lipid profiles, which reflected patient empowerment in a 'real life' context.

Is the treatment of the small saphenous veins with foam sclerotherapy at risk of deep vein thrombosis?

OBJECTIVE: To assess the deep vein thrombosis risk of the treatment of the small saphenous veins depending on the anatomical pattern of the veins. METHOD: A multicenter, prospective and controlled study was carried out in which small saphenous vein trunks were treated with ultrasound-guided foam sclerotherapy. The anatomical pattern (saphenopopliteal junction, perforators) was assessed by Duplex ultrasound before the treatment. All patients were systematically checked by Duplex ultrasound 8 to 30 days after the procedure to identify a potential deep vein thrombosis. RESULTS: Three hundred and thirty-one small saphenous veins were treated in 22 phlebology clinics. No proximal deep vein thrombosis occurred. Two (0.6%) medial gastrocnemius veins thrombosis occurred in symptomatic patients. Five medial gastrocnemius veins thrombosis and four cases of extension of the small saphenous vein sclerosis into the popliteal vein, which all occurred when the small saphenous vein connected directly into the popliteal vein, were identified by systematic Duplex ultrasound examination in asymptomatic patients. Medial gastrocnemius veins thrombosis were more frequent (p = 0.02) in patients with medial gastrocnemius veins perforator. A common outlet or channel between the small saphenous vein and the medial gastrocnemius veins did not increase the risk of deep vein thrombosis. CONCLUSION: Deep vein thrombosis after foam sclerotherapy of the small saphenous vein are very rare. Only 0.6% medial gastrocnemius veins thrombosis occurred in symptomatic patients. However, the anatomical pattern of the small saphenous vein should be taken into account and patients with medial gastrocnemius veins perforators and the small saphenous vein connected directly into the popliteal vein should be checked by Duplex ultrasound one or two weeks after the procedure. Recommendations based on our everyday practice and the findings of this study are suggested to prevent and treat deep vein thrombosis.

Prevalence and impact of constipation and bowel dysfunction induced by strong opioids: a cross-sectional survey of 520 patients with cancer pain: DYONISOS study.

OBJECTIVE: To describe the prevalence of opioid-induced constipation (OIC) in patients with cancer pain according to the Knowles-Eccersley-Scott symptom score (KESS), the different symptoms of opioid-induced bowel dysfunction (OIBD), and to assess the impact of OIBD on patient's quality-of-life. METHODS: A cross-sectional observational study, using the KESS questionnaire and the physician's subjective assessment of constipation, and other questionnaires and questions on constipation, OIBD, and quality-of-life, carried out on 1 day at oncology day centres and hospitals. RESULTS: Five hundred and twenty patients were enrolled at 77 centres in France; 61.7% of patients (n = 321) showed a degree of constipation that is problematic for the patient according to KESS (between 9-39). Even more patients, 85.7% (n = 438), were considered constipated according to the physician's subjective assessment-despite laxative use (84.7% of patients). Quality-of-life was significantly reduced in constipated vs non-constipated patients for both PAC-QoL (p < 0.0001 for total score and each dimension) and the SF-12 questionnaires (statistically significant for all dimensions except physical state and role physical). OIC and OIBD led to hospitalization (16% of patients), pain (75% of patients), and frequent changes in opioid and laxative treatment. KEY LIMITATIONS: This cross-sectional study, in a selected population of cancer patients, has measured prevalence and impact of OIBD. Further confirmation could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids. CONCLUSIONS: Cancer patients taking opioids for pain are very frequently constipated, even if they are prescribed laxatives. This leads to relevant impairments of quality-of-life.

Further validation of the psychometric properties of the Bowel Function Index for evaluating opioid-induced constipation (OIC).

OBJECTIVE: The BFI † (Bowel Function Index) is a 3-item questionnaire for assessing opioid-induced constipation (OIC). The aim of this study was to contribute to the validation of the psychometric properties of the BFI by confirming a constipation threshold, and through correlation with other validated tools: KESS (Knowles Eccersley Scott Symptom) score and generic (12-Item Short Form Health Survey, SF-12) and specific (Patient Assessment of Constipation-Quality of Life, PAC-QoL *) quality-of-life scores. METHODS: A survey on opioid-requiring cancer-patients was carried out in France. A questionnaire was filled out for all patients that recorded their demographic characteristics, an assessment of their constipation using BFI and KESS scores, and included a self-assessment of quality-of-life using PAC-QoL and SF-12. Correlation of BFI with KESS, PAC-QoL, and SF-12 was investigated. RESULTS: Five hundred and twenty patients participated in the entire data collection with no loss. BFI was shown to be statistically correlated (r = 0.571; p < 0.0001) with the KESS score and matches up with PAC-QoL and to a lesser extent with the SF-12 generic quality-of-life questionnaire. A BFI threshold of 27-29 to discriminate constipated from non-constipated patients was confirmed. KEY LIMITATIONS: This cross-sectional study in a selected population of cancer pain patients has validated the psychometric properties of the BFI. Further confirmation of the validity of the BFI could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids. CONCLUSION: This study contributes to the validation of the psychometric properties of the BFI. It confirms the BFI as an easy-to-use tool to assess constipation and its impact on quality-of-life in chronic pain patients.

Double-blind, randomized, crossover, controlled clinical trial of NaCl + Chitosan 3% versus NaCl on mild or moderate high blood pressure during the diet and lifestyle improvement period before possible prescription of an antihypertensive treatment.

AIM: The aim of the study was to examine the effect on blood pressure of replacing NaCl sea salt by NaCl + chitosan 3% (Symbiosal) during the diet and lifestyle improvement period prescribed to patients before any antihypertensive treatment. METHODS: This was a double-blind, randomized, crossover, controlled clinical trial of Symbiosal (NaCl + chitosan 3%) versus NaCl over two eight-week periods on 40 patients with mild hypertension for which they had never previously been treated. RESULTS: The effect of Symbiosal appeared as early as the first period of the crossover trial showing a reduction in systolic blood pressure (SBP) from 149.2 ± 4.9 mmHg to 136.1 ± 9.5 mmHg in patients on Symbiosal (reduction of 13.1 ± 10.8 mmHg) versus a reduction from 149.7 ± 4.6 mmHg to 142.9 ± 7.7 mmHg in patients on traditional NaCl (reduction of 6.8 ± 7.5 mmHg) (P=0.0404). Similar results were observed for diastolic blood pressure (DBP) with a reduction of 11.2 ± 7.4 mmHg versus 7 ± 8 mmHg (P=0.0560). HBP was brought under control (SBP ≤ 140 and DBP ≤ 90) in 76.2% (16/21) versus 36.8% (7/19)% of patients, respectively (P=0.0119). The crossover analysis confirmed the results showing Symbosial effects for both SBP (P=0.0156) and DBP (P=0.0285). CONCLUSION: Replacing traditional NaCl by Symbiosal in conjunction with recommended alterations to lifestyle and diet significantly contributes to better control of hypertension and may postpone the prescription of antihypertensive drugs.

Meta-analysis of the impact of the principal venoactive drugs agents on malleolar venous edema.

AIM: The aim of this study was to compare the reduction of venous ankle edema in randomized controlled trials of the main venoactive drugs versus a placebo or versus another venoactive drug and thereby to confirm or invalidate the existing recommendations on the pharmacological treatment of venous edema. METHODS: Publications of randomized controlled trials of venoactive drugs versus either a placebo or another venoactive drug on the reduction of ankle circumferences (AC) were searched through Medline and selected according to the Jadad and the Cucherat evaluation grids. RESULTS: Ten publications dated between 1975 and 2009 including a total of 1010 patients were identified for the meta-analysis. Included were the following venoactive drugs: micronised purified flavonoid fraction (MPFF), hydroxyethylrutoside, ruscus extracts and diosmin. The mean reduction in AC was -0.80 ± 0.53 cm with MPFF , -0.58 ± 0.47 cm with ruscus extract, -0.58 ± 0.31 cm with hydroxyethylrutoside, -0.20 ± 0.5 cm with single diosmin, and -0.11 ± 0.42 cm with placebo. The reduction in AC was significantly superior to that of placebo whatever the drug concerned (P<0.0001). The comparison between MPFF, ruscus extract and hydroxyethylrutoside on the reduction of ankle edema was in favour of MPFF. This was significant (P<0.0001), while the efficacy of the latter two venoactive agents was comparable. CONCLUSION: This meta-analysis confirms the validity of the grade A assigned to MPFF in the management of symptoms and edema in recent international guidelines.

RCT to evaluate a hyaluronic acid containing gauze pad in leg ulcers of venous or mixed aetiology.

OBJECTIVE: To investigate the efficacy and safety of an hyaluronic acid (HA)-impregnated gauze pad compared with a hydrocolloid (HC) dressing, in patients with leg ulcer of venous or mixed aetiology. METHOD: A 56-day blind-observer, randomised, multicentre, controlled, non-inferiority trial. Patients were randomised to receive either an HA gauze pad (ialuset gauze pad) or an HC dressing (DuoDERM E).The primary endpoint was the difference between the groups regarding the percentages of patients achieving a reduction of at least 40% of the initial wound surface after 56 days of treatment (visit 5). Secondary endpoints included reduction of wound area, aspect of the wound (percentage of necrotic,fibrinous or granulation tissue), rate of complete ulcer healing, pain intensity, and clinical status of the peri-ulcerous skin. RESULTS: In total, 170 patients were included and analysed in the intention-to-treat (ITT) population; 27 patients presented at least one major protocol deviation and were excluded from the per-protocol (PP) population.Therefore, 143 patients constituted the PP population (n=72 and n=71 in the HA gauze pad group and HC dressing group, respectively).At day 56, the confidence interval of the difference between the two groups for the percentage of patients with a reduction of at least 40% of the target ulcer initial surface was [-0.128; 0.164] with a lower limit above the non-inferiority threshold (-0.15). Peri-ulcerous skin was significantly less impaired in the HA gauze pad group for oedema at day 56 (p = 0.04), purpura at day 14 (p = 0.009) and for maceration at day 14 (p = 0.003). Other secondary endpoints were not significantly different between the two groups. Overall, both treatments were well tolerated and adverse events were comparable between the two groups regarding their pattern, frequency, likely relationship to treatment and severity which was mostly mild (grade I) or moderate (grade 2). These results were confirmed in the overall ITT population. CONCLUSION: These data support the non-inferiority of the HA gauze pad compared with HC for the primary endpoint.The significant differences in favour of HA gauze pad regarding peri-ulcerous skin changes (oedema, purpura and maceration) may suggest a trend for HA gauze pad to have a better acceptability than the reference HC dressing. DECLARATION OF INTEREST: This study was sponsored by Laboratoires Genévrier. Authors received honoraria for their contributions to the study, but have no other conflicts of interests to declare.