Metabolic Profiling Reveals Changes in Serum Predictive of Venous Ulcer Healing.

OBJECTIVE: The aim of this study was to identify potential biomarkers predictive of healing or failure to heal in a population with venous leg ulceration. SUMMARY BACKGROUND DATA: Venous leg ulceration presents important physical, psychological, social and financial burdens. Compression therapy is the main treatment, but it can be painful and time-consuming, with significant recurrence rates. The identification of a reliable biochemical signature with the ability to identify nonhealing ulcers has important translational applications for disease prognostication, personalized health care and the development of novel therapies. METHODS: Twenty-eight patients were assessed at baseline and at 20 weeks. Untargeted metabolic profiling was performed on urine, serum, and ulcer fluid, using mass spectrometry and nuclear magnetic resonance spectroscopy. RESULTS: A differential metabolic phenotype was identified in healing (n = 15) compared to nonhealing (n = 13) venous leg ulcer patients. Analysis of the assigned metabolites found ceramide and carnitine metabolism to be relevant pathways. In this pilot study, only serum biofluids could differentiate between healing and nonhealing patients. The ratio of carnitine to ceramide was able to differentiate between healing phenotypes with 100% sensitivity, 79% specificity, and 91% accuracy. CONCLUSIONS: This study reports a metabolic signature predictive of healing in venous leg ulceration and presents potential translational applications for disease prognostication and development of targeted therapies.

Healico-a wound care assistant in your pocket.

Non-optimal wound management and late referral to specialised units negatively impacts patient prognosis and quality of life, as well as healthcare costs. Healico is a new mobile application (app), created in the wound care field, in response to the challenges and difficulties encountered by health professionals (HPs) who deal with patients with wounds on a daily basis. This article aims to describe how this new app was developed, how it works, as well as the real-life clinical benefits and evidence supporting its use. The Healico App assists nurses, physicians and other HPs by: supporting a holistic approach to patient management; facilitating wound assessment and documentation, irrespective of where care is provided (primary, specialised or hospital services, in either public or private institutions); and supporting consistent and safe clinical practice, as well as reducing variation in care. It also provides a fast, fluid and secure communication channel, and effective coordination between HPs, supporting early interventions. The app has also been shown to improve therapeutic adherence of patients by promoting inclusive dialogue with them.

Aetiological treatment of venous leg ulcers with compression therapy: real-life outcomes with two different procedures.

OBJECTIVE: To evaluate the healing outcomes and costs associated with the aetiological management of venous leg ulcers (VLUs) treated with recommended multicomponent bandages (MCBs) and short-stretch bandages (SSBs). METHOD: This observational study is a retrospective comparative study (Level 2b), based on the French administrative healthcare database (Système National des Données de Santé, SNDS). It includes patients treated from onset with reimbursed MCBs and SSBs for a VLU episode, between July 2018 and September 2020. Although other compression systems, such as long-stretch bandages, are commonly used for the treatment of VLUs, they are not recommended by health authorities in France and thus, were not considered for this study. A binomial regression model was performed to estimate the adjusted relative risk of wound closure rates at three months for each group, based on potential confounding factors including, notably, age, sex, key comorbidities, and wound dressing size. The mean healthcare cost was calculated for patients whose VLUs healed within the study period. RESULTS: The reimbursement data (including prescribed compression systems and nursing care) of the 25,255 selected patients were analysed in the study. There were no significant differences between the MCBs and SSBs groups when considering patient characteristics. The healing rates after three months' treatment, were 42% and 35% (p<0.001) in the MCBs and SSBs groups, respectively. When adjusting the statistical model, the chance of healing at three months was still 12% higher with MCBs compared with SSBs (p<0.0001). The median healing time was estimated at 115 (interquartile range (IQR): 60-253) days in the MCB group versus 137 (IQR: 68-300) days in the SSBs group. The average treatment cost per patient with a healed ulcer was €2875±3647 in the MCB group and €3580±5575) in the SSBs group (p=0.0179), due to lower hospital stay and nursing costs in the MCB group. Differences in wound characteristics between the two groups cannot be totally excluded, due to the limited content of the database in terms of clinical data, but should have been addressed, to some extent, through the study selection criteria and the chosen regression model. CONCLUSION: In this study, this SNDS analysis seemed to confirm that the healing outcomes achieved in real-life with MCBs were in line with those reported in clinical trials, and superior to SSBs, which reinforces the current position from the guidelines.

TLC-Ag dressings: a prospective, multicentre study on 728 patients with wounds at risk of or with local infection.

OBJECTIVE: This study aimed to evaluate the management of an unselected cohort of patients with wounds at risk of or with clinical signs of local infection, treated with two antimicrobial contact layers impregnated with silver (TLC-Ag healing matrix), under real-life conditions during the COVID-19 pandemic. METHOD: A large, prospective, multicentre, observational study with two TLC-Ag dressings (UrgoTul Ag/Silver and UrgoTul Ag Lite Border, Laboratoires Urgo, France) was conducted in Germany between May 2020 and May 2021. The main outcomes included a description of the treated patients and their wound management, the changes in wound infection and wound healing outcomes over a maximum period of four weeks of treatment, as well as the overall clinical assessment of the performance, local tolerance and acceptability of dressings. RESULTS: A total of 728 patients with wounds of various aetiologies and wound infection status were treated with the evaluated dressings in 39 centres for a mean duration of 26±19 days, with an intermediate visit conducted in 712 (97.8%) patients after a mean period of 12±9 days. At the initial visit, it was established that the majority of patients (60.4%) had a wound infection, while the remaining cohort presented first clinical signs of a local wound infection (25.1%) or were at risk of wound infection (13.2%) (unclear status in 1.2%). Throughout the study period, all the parameters of wound infection continuously decreased, resulting at the final visit in a reduction by 78.9% of the prevalence of local wound infections and by 72.0% of the clinical signs of wound infection, the most rapidly diminished clinical sign being wound deterioration. Concurrently, in terms of the healing process, 92.1% of the wounds healed or improved, 3.2% remained unchanged and 1.7% worsened (data missing for 3.0%), and an improvement of the periwound skin was reported in 65.7% of the patients. Overall, the two dressings were 'very well accepted' by the majority of patients, with no uncomfortable feeling at wearing and no pain at dressing removal, and were assessed by the physicians as 'very useful' in the majority of the cases with a 'very good' efficacy in terms of antimicrobial activity and promotion of the wound healing process. Similar results were reported regardless of the wound type treated or of the TLC-Ag dressing evaluated. CONCLUSION: These results are consistent with previous clinical evidence on TLC-Ag dressings. They support the good efficacy, good tolerability and usefulness of these antimicrobial dressings in the management of patients with wounds at risk or with clinical signs of local infection, in association with appropriate standard of care.

Evolution of the TcPO2 values following hyperoxygenated fatty acids emulsion application in patients with diabetic foot disease: results of a clinical trial.

OBJECTIVE: The use of emollients to lubricate dry skin to prevent diabetic foot ulcers (DFUs), especially in neuroischaemic feet, has been recommended. This study analyses the effect of daily topical application of hyperoxygenated fatty acids emulsion on transcutaneous oxygen pressure (TcPO2) in the feet of neuropathic and neuroischaemic patients with diabetes. METHOD: Patients with diabetes and no active foot ulcer were included in this longitudinal, prospective, non-comparative clinical trial. The evolution of TcPO2 (mmHg) values after the application of the tested emulsion (Corpitol Emulsion, Laboratoires Urgo Medical, France) was evaluated for a three-month period. Modifications of skin features (skin dryness, skin shedding and skin colour) were also analysed. TcPO2 was performed using a TCM400 device (Radiometer, Denmark). RESULTS: A total of 50 patients were included in the study. Patients with neuroischaemia showed a significant increase in TcPO2 values (35.69±13.88mmHg) after two months' application of the tested emulsion that remained at month three (day 60: 42.34±10.98mmHg; p=0.006; day 90: 41.62±10.88mmHg; p=0.011). Skin dryness and shedding showed an improvement from baseline to the end of the study in both groups, secondary to the use of the tested emulsion (p<0.001 and p<0.001, respectively). Skin colour also showed differences from baseline to the final visit in the neuroischaemic patients (p=0.029). Patients with neuropathy did not show any change in skin colour from baseline to the final visit. CONCLUSIONS: Analysis of the use of the tested emulsion showed an increase in TcPO2 and an improvement in skin trophism in patients with neuroischaemic foot.

Clinical evaluation of UrgoStart Plus dressings in real-life conditions: results of a prospective multicentre study on 961 patients.

AIMS: This study aimed to evaluate the performances of lipid colloid technology with nano-oligosaccharide factor (TLC-NOSF) dressings with polyabsorbent fibres in an unselected population of patients under real-life conditions. METHODS: A large, prospective, multicentre, observational study with three polyabsorbent TLC-NOSF dressings (UrgoStart Plus Pad, UrgoStart Plus and UrgoStart Plus Border, Laboratoires Urgo, France) was conducted in Germany between January 2019 and June 2020. Main outcomes included wound healing rate, clinical assessment of wound healing progression, local tolerance and acceptance of dressings, and changes in health-related quality of life (HRQoL) of the patients, assessed with the validated Wound-QoL questionnaire. RESULTS: A total of 961 patients with wounds of various aetiologies (leg ulcers (LU), diabetic foot ulcers (DFU), pressure ulcers (PU) and other types of wounds) were treated with the evaluated dressings in 105 centres for a mean duration of 62 days (standard deviation 37 days). By the last visit, a wound closure or an improvement in wound healing was reported in 92.0% of the treated wounds. The highest wound closure rates were achieved when the dressings were used as first-line treatment: 71.3% in DFUs, 52.9% in LUs, 53.6% in PUs and 61.8% in the other wounds. Improvement of the wound healing process was also associated with an 87.5% relative reduction of sloughy tissue, a decrease of the level of exudate in 68.9% of the wounds, and an improvement in the periwound skin condition in 66.4% of the patients at the final visit. The dressings were 'very well' or 'well' tolerated and 'very well' or 'well' accepted by the large majority of patients. The HRQoL questionnaires were completed both at initial and final visits by 337 patients, representative of the total cohort. Despite the relatively short duration of the wounds, the HRQoL of the patients was already impaired at baseline, with 81.6% of the patients being severely affected in at least one aspect of their HRQoL. By the final visit, significant improvements in each dimension of the patients' HRQoL were reported (p<0.001), along with a reduction of the proportion of patients in need of intervention and in the number of actions needed per patient in relation to their HRQoL. CONCLUSIONS: These results are consistent with previous clinical evidence on TLC-NOSF dressings. They confirm the good healing properties and safety profile of these dressings, and that a significant improvement in patient HRQoL is achieved in non-selected patients treated in real-life practice. These data support the use of such dressings as a first-line intervention and until wound healing in the management of chronic wounds, in association with appropriate standard of care.

Use of a TLC-Ag dressing on 2270 patients with wounds at risk or with signs of local infection: an observational study.

OBJECTIVE: A description of wounds treated with a poly-absorbent silver dressing (with technology lipido-colloid with silver ions, TLC-Ag), and evaluation of the short-term clinical impact of the dressing on the wound healing process, under real-life conditions. METHOD: A large, prospective, multicentre, observational study of patients in 81 centres in Germany, presenting with an exuding wound at risk or with clinical signs of local infection for whom the evaluated TLC-Ag dressing (UrgoClean Ag, Laboratoires Urgo, France) has been prescribed. Main outcomes included: reduction in number of wound infections diagnosed and clinical signs of local infection, wound healing rate, clinical assessment of wound healing progression, relative wound area reduction (RWAR), local tolerability, handling and acceptance of the dressing. RESULTS: A total of 2270 patients with acute and chronic wounds of various aetiologies were treated with the evaluated dressing for a mean duration of 22±13 days. All clinical signs of local infection and the diagnosed wound infections were substantially reduced at two weeks after the treatment initiation. All wound infection parameters continued to reduce until the last visit. In the meantime, clinical improvement in wound healing was reported in 98.9% of acute wounds, with a wound closure rate of 68.5%. In chronic wounds, a median RWAR of 57.4% was achieved, with an improvement in healing process documented by clinicians in 90.6% of cases, stabilisation in 6.1% and worsening in 3.2%. Similar results were reported, regardless of exudate level and proportion of sloughy and granulation tissues in the wound bed at baseline. The dressing was well tolerated and well accepted by both patients and health professionals. CONCLUSION: These results, documented in a large cohort of patients treated in current practice, support and complete the clinical evidence on the healing properties and safety profile of the TLC-Ag dressing in the management of wounds at risk or with clinical signs of local infection, regardless of wound and patient characteristics. Declaration of interest: This study was supported by a grant from Laboratoires Urgo. UM, EB, LT and SB are employees of Laboratoires Urgo. JD, KCM and MD provided advisory and speaking services to pharmaceutical and other healthcare organisations including, but not limited to, Laboratoires Urgo. Data management and statistical analyses were conducted independently by INPADS GmbH, Germany.

Clinical evaluation of polyabsorbent TLC-NOSF dressings on chronic wounds: a prospective, observational, multicentre study of 1140 patients.

OBJECTIVE: The superior wound healing properties and cost-effectiveness of TLC-NOSF dressings in the local treatment of chronic wounds have already been demonstrated by several randomised controlled trials (RCTs) at a high quality level. Therefore, this study aimed to evaluate the efficacy and safety of new TLC-NOSF dressings with polyabsorbent fibres in an unselected population of patients under real-life conditions. METHOD: A large, prospective, multicentre, observational study with two polyabsorbent TLC-NOSF dressings (UrgoStart Plus Pad and UrgoStart Plus Border, Laboratoires Urgo, France) was conducted in Germany between July 2017 and December 2018. Main outcomes included wound healing rate, clinical assessment of wound healing progression, local tolerability and acceptance of dressings. RESULTS: A total of 1140 patients with chronic wounds of various aetiologies (leg ulcers, diabetic foot ulcers, pressure ulcers, etc.) were treated with the investigated dressings in 130 centres, for a mean duration of 56±34 days. By the final visit, 48.5% of wounds had healed and 44.8% had improved. Similar results were reported regardless of wound aetiology or regardless of proportions of sloughy and granulation tissue at the start of treatment. According to the subgroup analysis by wound duration, the sooner the TLC-NOSF treatment was initiated, the better the clinical outcomes for all types of wounds. The dressings were very well tolerated and accepted by the patients. CONCLUSION: These results are consistent with those from RCTs conducted on TLC-NOSF dressings. They complete the evidence on the good healing properties and safety profile of these dressings, especially in non-selected patients treated in current practice, and regardless of the characteristics of wounds and patients. They support the use of the dressings as a first-line intervention and until wound healing in the management of chronic wounds, in association with appropriate standard of care.

Evaluation of TLC-NOSF dressing with poly-absorbent fibres in exuding leg ulcers: two multicentric, single-arm, prospective, open-label clinical trials.

OBJECTIVE: To assess the efficacy, safety and acceptability of a new TLC-NOSF dressing with poly-absorbent fibres in the management of exuding leg ulcers, at the different stages of healing. METHOD: This work presents the results of two prospective, multicentric clinical studies: NEREIDES and CASSIOPEE. Patients with a non-infected, moderate-to-strongly exudating leg ulcer of venous or mixed origin, were treated with the dressing and an appropriate compression system for 12 weeks. The wounds included in NEREIDES had to be in debridement stage, and those in CASSIOPEE at granulation stage. In both studies, the primary outcome was the relative wound area reduction (RWAR) at week 12. Main secondary outcomes included healing rate, time-to-reach wound closure, adverse events and acceptability of the dressing by patients and health professionals. RESULTS: There were 37 patients included in NEREIDES and 51 in CASSIOPEE. The two cohorts presented similar patient and wound characteristics, except from the percentage of sloughy tissue on wound bed at baseline (median: 75% NEREIDES and 30% CASSIOPEE). At week 12, the RWAR (60% NEREIDES and 81% CASSIOPEE), wound closure rates (18% NEREIDES and 20% CASSIOPEE) and mean times-to-reach wound closure (58±27 days NEREIDES and 55±23 days CASSIOPEE) supported the beneficial outcomes of the treatment in both cohorts. In patients with a wound duration ≤6 months, the wound area reduction reached 85% in NEREIDES and 81% in CASSIOPEE, highlighting the importance to initiate adequate treatment as soon as possible. The nature and frequency of the local adverse events were similar in both studies and consistent with the good safety profiles of the poly-absorbent fibres and of the TLC-NOSF dressings. The acceptability of the dressing (easy to apply, conformable and non-adherent to the wound bed at removal, with no pain or bleeding at removal) has been judged 'very good' or 'good' at each stage of the healing process, by both nursing staff and patients. CONCLUSION: These clinical results establish the new TLC-NOSF dressing with poly-absorbent fibres (UrgoStart Plus, Laboratoires Urgo) as an effective, safe and simple treatment for the local management of leg ulcers, at the different stages of healing and until wound closure.

Optimal wound closure of diabetic foot ulcers with early initiation of TLC-NOSF treatment: post-hoc analysis of Explorer.

OBJECTIVE: In March 2018, the Explorer study, an international, double-blind, randomised controlled trial (RCT), established that adding a TLC-NOSF (UrgoStart Contact, Laboratoires Urgo, France) dressing to good local standard of care (SoC) significantly and substantially increases wound closure and reduces the healing time of neuroischaemic diabetic foot ulcers (DFU). Besides the TLC-NOSF treatment, the wound duration was the only other covariate that had an influence on the wound closure rate in the regression model used in the original study. The purpose of this work was to further document the impact of wound duration on the healing outcomes of the DFUs included in the Explorer study and to discuss complementary pragmatic observations on the TLC-NOSF effect. METHOD: In this post-hoc analysis of the Explorer data, the wound closure rates by week 20 are reported for the global cohort (n=240, Intention-to-treat population) and for the treated (n=126) and control groups (n=114) according to DFU duration and location. RESULTS: For the combined group, wound closure rates decreased with the increase of wound duration at baseline (from 57% in wounds ≤2 months to 19% in wounds >11 months). Whatever the wound duration subgroups analysed, higher closure rates were reported in the TLC-NOSF group than in the control group. However, the maximal difference between the two treatments was reported in wounds with a duration of ≤2 months (71% versus 41%, 30 percentage points difference, Relative Risk 1.7, 95% Confidence Interval 1.1 to 2.8). Regarding wound location subgroup analyses, the outcomes were always in favour of the TLC-NOSF treatment, with closure rates ranging between 43% and 61% within the TLC-NOSF group, and between 25% and 40% within the control group. CONCLUSION: This clinical evidence supports that treating DFUs with TLC-NOSF dressing and good SoC results in higher wound closure rates than with a neutral dressing and the same good standard of care, whatever the duration and the location of the treated wounds. However, the earlier the TLC-NOSF dressing is initiated in DFU treatment, the greater the benefits.

Cavity wounds management: a multicentre pilot study.

The objective of this study was to assess acceptability (based on pain at removal), efficacy and tolerance of an absorbent and cohesive rope(UrgoClean Rope, Laboratoires Urgo) in the local management of deep cavity wounds. This study was a prospective, multicentre (13), non comparative clinical study. Patients presenting with an acute or chronic non-infected cavity wound were followed up for four weeks and assessed weekly with a physical examination, in addition to volumetric,planimetric and photographic evaluations. Pain at removal was the primary criterion, assessed on a Visual Analogic Scale. The percentage of the wound surface area reduction and volumetric reduction were considered as secondary efficacy criteria. Forty three patients were included in this study. After one week of treatment dressing removal was painless and continued to be so throughout the period of the trial(four weeks). Median surface area at baseline was 7.74 cm2 and was reduced by 54.5% at week 4 (relative area reduction). Median wound volumetric value was noted 12 ml at baseline and was reduced by 72.7% by the end of treatment. The cohesiveness of the new rope was considered very good by health professionals. No residue was observed on the wound bed during the dressing change with the new rope. There were no adverse events related to the tested rope, during this trial.Pain-free removal associated with good efficacy and tolerance were observed with this new cohesive rope in the healing process of deep cavity wounds and could represent a therapeutic alternative to the usual ropes used in such indications.

Postabdominoplasty Scar Improvement after a Single Session with an Automated 1210-nm Laser.

Abdominoplasty, one of the most commonly performed aesthetic procedures, aims at correcting excess abdominal skin and fat, but generates a long abdominal scar. The efficacy of an automated portative 1210-nm laser in improving the appearance of surgical scars has been previously demonstrated in a double-blind randomized controlled trial. The purpose of this work was to document the use of this laser in real-life practice. Methods: Eighteen patients undergoing abdominoplasty and treated with the evaluated laser (UrgoTouch, Laboratoires Urgo; one single session immediately after the surgery) were included in this prospective, mono-center, observational study. Change in scar characteristics was assessed using the validated Observer Scar Assessment Scale, and the patients' and surgeon's satisfaction was rated using a four-point scale. Results: The aesthetic outcome of the scars was very positive with a mean Observer Scar Assessment Scale score of 17.0 (SD 4.6) and 14.4 (SD 3.8) on the 6-60 point scale (60: the worst possible outcome) at 6 and 12 months, respectively. A high degree of satisfaction was also expressed by both surgeon and patients at 6 weeks, 6 months, and 12 months. No laser-related incident was reported during the study, including in patients with darker phototypes. Conclusions: These findings seem to be consistent with previous clinical evidence on the use of this laser on fresh incisions. The high degree of satisfaction reported by both surgeon and patients seems to comfort the benefits of this procedure at short- and long-term and support the use of this laser in daily practice of plastic surgery.

Microcirculation Improvement in Diabetic Foot Patients after Treatment with Sucrose Octasulfate-Impregnated Dressings.

To assess the patients' microcirculation evolution during the treatment with a sucrose octasulfate-impregnated dressing, fifty patients with neuroischaemic DFU treated with TLC-NOSF dressing were included in a prospective study between November 2020 and February 2022. TcpO2 values were measured on the dorsalis pedis or tibial posterior arteries' angiosome according to the ulcer location. TcpO2 values were assessed at day 0 and every 4 weeks during 20 weeks of the follow-up or until the wound healed. A cut-off point of tcpO2 < 30 mmHg was defined for patients with impaired microcirculation. The TcpO2 values showed an increase between day 0 and the end of the study, 33.04 ± 12.27 mmHg and 40.89 ± 13.06 mmHg, respectively, p < 0.001. Patients with impaired microcirculation showed an increase in the tcpO2 values from day 0 to the end of the study (p = 0.023). Furthermore, we observed a significant increase in the TcpO2 values in the forefoot DFU (p = 0.002) and in the rearfoot DFU (p = 0.071), with no difference between the ulcer locations (p = 0.694). The local treatment with TLC-NOSF dressing improved the microcirculation in patients with neuroischaemic DFU, regardless of microcirculation status at the baseline, and in the forefoot, regardless of the location.

A randomized, controlled, double-blind prospective trial with a Lipido-Colloid Technology-Nano-OligoSaccharide Factor wound dressing in the local management of venous leg ulcers.

Venous leg ulcers (VLUs) are the most prevalent chronic wounds in western countries with a heavy socioeconomic impact. Compression therapy is the etiologic treatment of VLU but until now no wound dressing has been shown to be more effective than another. The aim of this study was to assess the efficacy of a new dressing in the management of VLU. Adult patients presenting a noninfected VLU and receiving effective compression therapy were enrolled in this randomized, controlled, double-blind trial. The VLUs were assessed every 2 weeks for 8 weeks. The primary study outcome was the relative Wound Area Reduction (WAR, in %), and the secondary objectives were absolute WAR, healing rate, and percentage of wounds with >40% surface area reduction. One hundred eighty-seven patients were randomly allocated to treatment groups. Median WAR was 58.3% in the Lipido-Colloid Technology-Nano-OligoSaccharide Factor (TLC-NOSF) dressing group (test group) and 31.6% in the TLC dressing group (control group) (difference: -26.7%; 95% confidence interval: -38.3 to -15.1%; p = 0.002). All other efficacy outcomes were also significant in favor of the TLC-NOSF dressing group. Clinical outcomes for patients treated with the new dressing are superior to those patients treated with the TLC dressing (without NOSF compound), suggesting a strong promotion of the VLU healing process.

Effectiveness of Sucrose Octasulfate Dressing in the Treatment of Neuro-Ischaemic Diabetic Foot Heel Ulcers: A Retrospective Single arm Study.

The study aimed to evaluate the effectiveness of the use of sucrose octasulfate impregnated dressing (TLC-NOSF [Technology Lipido-Colloid-Nano-OligoSaccharide Factor]) in the management of persons with neuro-ischaemic heel diabetic foot ulcers (DFUs). Consecutive patients who referred for an active non-infected neuro-ischaemic heel DFU belonging to grade IC (superficial) or IIC (deep to tendons, muscle or capsule) according to Texas University Classification were included. All patients were managed by a pre-set limb salvage protocol in the respect of International guidelines and the TLC-NOSF dressing was used as primary and specific dressing. Patients were evaluated any 2 to 4 weeks until wound healing or different outcomes. Primary outcome was the rate of complete wound healing after 24 weeks of follow-up. The secondary outcomes assessed the healing time, the rate of wound regression, the re-ulceration in the case of complete healing and the safety. Thirty patients were included. The mean age was 67 ± 11 years, 17 (56.7%) were male, all of them were affected by type 2 diabetes with a mean duration of 18 ± 7 years. Twenty patients (66.7%) showed deep ulcers (grade 2 of Texas University Classification); the mean TcPO2 at the inclusion was 42 ± 7 mm Hg. Twenty-two patients (73.3%) healed by Week 24. The mean time of healing was 84 ± 32 days, 2 (6.7%) patients had ulcer relapse after healing, 28 (93.3%) had wound regression >50%, 2 (6.7%) had mild infection, 1 (3.3%) reported major amputation. No serious adverse events related to TLC-NOSF dressing or local reactions were reported. This current study showed the potential benefit of sucrose octasulfate for treating neuro-ischaemic heel DFUs in addition to the standard of care.

Increasing Transcutaneous Oxygen Pressure in Patients With Neuroischemic Diabetic Foot Ulcers Treated With a Sucrose Octasulfate Dressing: A Pilot Study.

Regarding the positive clinical outcomes of sucrose octasulfate impregnated dressing documented in neuroischemic diabetic foot ulcers (DFUs), we aimed to evaluate the microcirculatory status in patients with neuroischemic DFU through the use of sucrose octasulfate dressing. Eleven patients with neuroischemic DFU were included in a prospective pilot study between July 2019 and March 2020. We evaluated the effect in transcutaneous oxygen pressure (TcPO2; mm Hg) values within the use of a sucrose octasulfate dressing in the course of the healing process of neuroischemic DFUs (UrgoStart Contact, Laboratoires Urgo Medical). TcPO2 values were assessed at day 0 and monthly until wound healing was achieved. Additionally, wound healing process was evaluated using the Wollina score system and wound area surface, at day 0 and monthly until 20 weeks of follow-up or wound healing first occurred. TcPO2 values showed a significant increase between day 0 (29.45 ± 7.38 mm Hg) and wound closure (46.54 ± 11.45 mm Hg, P = .016), after dressing application. Wollina wound scores showed a significant improvement (4.2 ± 1.7 at day 0 to 5.4 ± 1.3 at the end of the study; P = .004). Median wound area at day 0 was 1.30 cm2, interquartile range [1.60-1] cm2, and 0.5 cm2 at week 4, interquartile range [1.1-0.1], P < .001. Median healing time was 8 weeks, interquartile range [8-5]. Treating a neuroischemic DFU with a sucrose octasulfate dressing in the standard of care showed an increase in skin oxygen pressure.

Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France.

This study assesses the cost-effectiveness of Technology Lipido-Colloid with Nano Oligo Saccharide Factor (TLC-NOSF) wound dressings versus neutral dressings in the management of diabetic foot ulcers (DFUs) from a French collective perspective. We used a Markov microsimulation cohort model to simulate the DFU monthly progression over the lifetime horizon. Our study employed a mixed method design with model inputs including data from interventional and observational studies, French databases and expert opinion. The demographic characteristics of the simulated population and clinical efficacy were based on the EXPLORER double-blind randomized controlled trial. Health-related quality of life, costs, and resource use inputs were taken from the literature relevant to the French context. The main outcomes included life-years without DFU (LYsw/DFU), quality-adjusted life-years (QALYs), amputations, and lifetime costs. To assess the robustness of the results, sensitivity and subgroup analyses based on the wound duration at treatment initiation were performed. Treatment with the TLC-NOSF dressing led to total cost savings per patient of EUR 35,489, associated with gains of 0.50 LYw/DFU and 0.16 QALY. TLC-NOSF dressings were established as the dominant strategy in the base case and all sensitivity analyses. Furthermore, the model revealed that, for every 100 patients treated with TLC-NOSF dressings, two amputations could be avoided. According to the subgroup analysis results, the sooner the TLC-NOSF treatment was initiated, the better were the outcomes, with the highest benefits for ulcers with a duration of two months or less (+0.65 LYw/DFU, +0.23 QALY, and cost savings of EUR 55,710). The results from the French perspective are consistent with the ones from the German and British perspectives. TLC-NOSF dressings are cost-saving compared to neutral dressings, leading to an increase in patients' health benefits and a decrease in the associated treatment costs. These results can thus be used to guide healthcare decisionmakers. The potential savings could represent EUR 3,345 per treated patient per year and even reach EUR 4,771 when TLC-NOSF dressings are used as first line treatment. The EXPLORER trial is registered with ClinicalTrials.gov, number NCT01717183.

The Role of a Silver Releasing Lipido-colloid Contact Layer in Venous Leg Ulcers Presenting Inflammatory Signs Suggesting Heavy Bacterial Colonization: Results of a Randomized Controlled Study.

UNLABELLED: Objective. Clinical interest of silver in the management of chronic wounds is not fully established. The main objective of this clinical study was to assess the ability of a new silver releasing lipido-colloid contact layer to promote the healing process of venous leg ulcers (VLU) presenting inflammatory signs suggesting a heavy bacteria colonization and then a delayed healing, in comparison to the same wound dressing not impregnated with silver salts. METHODS: This was an open-labeled, randomized, controlled trial. VLU presenting at least 3 out of 5 clinical signs suggesting heavy bacterial colonization were recruited. Patients were treated with contact layer silver dressing ([CLS], Restore® Contact Layer, Silver* (Hollister Wound Care, Libertyville, Ill) or contact layer dressing ([CL] Restore® Contact Layer**, Hollister Wound Care, Libertyville, Ill) for 4 weeks, then all treated ulcers were treated with CL for the 4 additional weeks. Wound evaluation and area measurements were conducted weekly during the first 4 weeks and then at week 6 and 8. Main efficacy criterion was absolute wound area decrease (AD) at week 4 and week 8. RESULTS: Patients (N = 102) were randomized and treated. Ulcers were present for nearly 11 months on average; 65% were recurrent and mean area was 20.0 ± 17.8 cm2. Almost 80% of the treated VLU were stagnating/aggravating with their previous treatment. By week 4, mean surface area decreased by 6.5 ± 13.4 cm2 (median: 4.2 cm2) and 1.3 ± 9.0 cm2 (median: 1.1 cm2) in CLS and CL groups, respectively (P = 0.023). At week 8, median decrease was 5.9 cm2 versus 0.8 cm2 (P = 0.002) with a wound percentage decrease of 47.9% and 5.6% (P = 0.036). Median closure rate was 0.145 versus 0.044 cm2/day (P = 0.009) at week 4 and remained higher in the CLS group up to week 8 even after switching to CL dressing in these patients (P = 0.001). Odds ratio (multinomial logistic regression) of the chance to reach a ≥ 40% wound area reduction was 2.7 (95% CI: 1.1 to 6.7; P = 0.038) for silver treated ulcers. Dressing tolerance was good in both groups. CONCLUSION: A 4-week treatment with silver releasing lipido-colloid contact layer promotes a sustained increase of closure rate of venous leg ulcers presenting inflammatory signs suggesting a high bacterial load. Also marketed as *Urgotul® Silver and **Urgotul®, Laboratoires Urgo, (France)..

Evaluation of the nano-oligosaccharide factor lipido-colloid matrix in the local management of venous leg ulcers: results of a randomised, controlled trial.

The nano-oligosaccharide factor (NOSF) is a new compound aiming to promote wound closure mainly through inhibition of matrix metalloproteinase (MMP) activity. This factor is incorporated within a lipido-colloid matrix (Techonology Lipido-Colloid-NOSF matrix) and locally released in the wound. The objective of this study was to document the performance (non inferiority or superiority) of the NOSF relative to the Promogran matrix (oxidised regenerated cellulose, ORC) effect in the local management of venous leg ulcers (VLUs). This was a 12-week, open, two-arm, multicentre, randomised study. Patients were selected if the area of their VLU [ankle brachial pressure index >or=0.80] ranged from 5 to 25 cm(2) with a duration >or=3 months. Ulcers had to be free from necrotic tissue. In addition to receiving compression bandage therapy, patients were randomly allocated to either NOSF matrix or ORC treatment for 12 weeks. The VLUs were assessed on a weekly basis and wound tracings were recorded. Percentage wound relative reduction (%RR) was the primary efficacy criterion. Secondary objectives were wound absolute reduction (AR), healing rate (HR) and % of wounds with >or=40% reduction compared with baseline. A total of 117 patients were included (57 NOSF matrix and 60 ORC). Mean population age was 71.3 +/- 13.5 years, body mass index was >or=30 kg/m(2) in 39.3% and 15.4% were diabetics. Fifty-six per cent of the VLUs were present for >6 months, 61% were recurrent and 68% were stagnating despite appropriate care. Mean wound area at baseline was 11.2 +/- 7.4 cm(2). At the last evaluation, mean difference between the groups for %RR was 33.6 +/- 15.0% in favour of NOSF matrix with a unilateral 95% confidence interval (CI) lower limit of 8.6% not including the null value. Therefore, a superiority of NOSF matrix effect compared with ORC was concluded (P = 0.0059 for superiority test). The median of the wound area reduction was 61.1% and 7.7% in the NOSF matrix and control groups, respectively (per-protocol analysis), or 54.4% versus 12.9% in intent-to-treat analysis (p = 0.0286). Median AR was 4.2 cm(2) in the NOSF group and 1.0 cm(2) with ORC (P = 0.01). Median HR was -0.056 and -0.015 cm(2)/day in NOSF and ORC groups, respectively (P = 0.029). By logistic regression, the NOSF versus control odds ratio to reach 40% area reduction was 2.4 (95% CI: 1.1-5.3; P = 0.026). In the oldest and largest VLUs, a strong promotion of healing effect was particularly observed in the NOSF matrix group compared with the control group. NOSF matrix is a very promising option for the local management of chronic wounds, especially for VLUs with poor healing prognosis.

A comparison of inferface pressures of three compression bandage systems.

OBJECTIVE: To measure and compare the interface pressures achieved with two compression bandage systems - a four-layer system (4LB) and a two-layer short-stretch system (SSB) - with a new two-layer system (2LB), which uses an etalonnage (performance indicator) to help achieve the correct therapeutic pressure for healing venous leg ulcers - recommended as 40 mmHg. METHOD: 32 nurses with experience of using compression bandages applied each of the three systems to a healthy female volunteer in a sitting position. The interface pressures and time taken to apply the systems were measured. A questionnaire regarding the concept of the new system and its application in comparison to the existing two systems was then completed by the nurses. RESULTS: The interface pressures achieved show that many nurses applied very high pressures with the 4LB (25% achieving pressures > 50 mmHg) whereas the majority of the nurses (75%) achieved a pressure of < 30 mmHg when using the SSB. A pressure of 30-50 mmHg was achieved with the new 2LB. The SSB took the least time to be applied (mean: 1 minute 50 seconds) with the 4LB the slowest (mean: 3 minutes 46 seconds). A mean time of 2 minutes 35 seconds was taken to apply the 2LB. Over 63% of the nurses felt the 2LB was very easy to apply. CONCLUSION: These results suggest that the 2LB achieves the required therapeutic pressure necessary for the management of venous leg ulcers, is easy to apply and may provide a suitable alternative to other multi-layer bandage systems.