Objective: This study aimed to evaluate the performance of an innovative multicomponent compression system in a single bandage (UrgoK1, Laboratoires Urgo, France) in the treatment of patients with venous leg ulcers (VLUs) and/or lower limb oedema in everyday practice. Method: A prospective, observational, clinical study with the evaluated compression system was conducted in 39 centres in Germany between March 2022 and July 2023. Main outcomes included a description of the treated patients, changes in wound healing and oedema progression, local tolerance and acceptability of the compression system. Results: In total, 343 patients were treated with the evaluated compression system for a mean period of 48±30 days; 196 had a VLU and 275 had oedema, mostly of venous origin. By the final visit, 49% of VLUs healed (75% in absence of oedema and 61% in VLUs of ≤1 month's duration). Oedema was completely resolved or greatly improved in 87% of patients, with significant reduction in calf and ankle circumferences. Improvement in pruritus, pain, age-related ankle mobility and skin changes were also reported in patients who experienced them at baseline. The system was judged ‘very easy’ to apply (median: 108 seconds, three times a week), ‘extremely useful’ and ‘very well accepted’ by most patients who reported an improvement in comfort compared with previous systems. Similar results were observed when patients and/or their relatives were involved in the bandage application between the study visits. During the study, three cases of local intolerance related to the system and five early terminations (unrelated to the system) were reported. Conclusion: These results are consistent with the previous clinical evidence available on this new compression system and further support its good efficacy, tolerability, acceptability and usefulness in the treatment of patients with VLUs and/or oedema. Declaration of interest: This study was supported by a grant from Laboratoires Urgo, France. EH, UM and LT are employees of Laboratoires Urgo. CS, TB, WK, MS and JD provide 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.
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