J Wound Care. 2026 Jan 2;35(1):4-14. doi: 10.12968/jowc.2025.0535. Epub 2025 Dec 23.
ABSTRACT
OBJECTIVE: This study was performed to assess the clinical performance of a multicomponent reduced compression system (applying ~20mmHg) and dressings based on lipido-colloid technology with nano-oligosaccharide factor (TLC-NOSF) in the management of patients with venous leg ulcers (VLUs) and mixed leg ulcers (MLUs with arterial component).
METHOD: A prospective, multicentre, non-comparative clinical trial was conducted in the Angiology and Vascular Surgery Units in three hospitals in Madrid, Spain. Adults with VLUs or MLUs, confirmed by an ankle-brachial pressure index >0.6, were treated with UrgoK2 Lite Latex Free and UrgoStart dressings (both Laboratoires Urgo, France) for 12 weeks. The primary endpoint was complete ulcer closure by week 12. Secondary endpoints included time-to-heal, change in wound area, leg oedema resolution, change in ankle circumference, ease of application and adherence to compression therapy, adverse events (AEs), and acceptability of the treatment strategy.
RESULTS: A total of 45 patients with LUs (mean age 70.0 years; 64% male; 44% obese) were included. Based on vascular assessment, 24 patients had VLUs and 21 had MLUs, associated with leg oedema in 89% of cases. The LUs were recurrent in 60% of cases, and lasted ≥6 months in 58% of cases. The wound areas were relatively large (median value: 9.4cm2, interquartile range (IQR): 5.9-11.8cm2), and mostly covered by sloughy tissue. Impaired perilesional skin was reported in 93% of patients. By the final visit, 71% of VLUs had healed, 25% had improved and 4% remained unchanged. Despite an initial poorer healing prognosis than for VLUs, 43% of MLUs healed and 43% improved. The median time-to-heal was nine weeks (IQR: 6-11 weeks), with no relevant difference between the two types of leg ulcer (LU). These good healing progressions were also supported by consistent and steady reductions in wound surface area throughout the 12 weeks of treatment, regardless of LU aetiology, resulting in a relative wound area reduction of 100% (median value; IQR: 93.8-100.0%) in VLUs and 98.6% (median value; IQR: 55.6-100.0%) in MLUs. Leg oedema resolved in all patients by week 8 (except two missing data), while mean ankle circumference reduced from 24.5±2.7cm at baseline to 21.4±2.4cm at final measurement. The application of the compression system was judged 'very easy' in 85% of cases and 'easy' in 15%. Full adherence to compression therapy was reported in 80% of patients during the first weeks of treatment and increased to 97% by week 8. Only two AEs, unrelated to the evaluated treatments, were reported throughout the study period. At the final visit, the association of the multicomponent reduced compression system and TLC-NOSF dressings in the management of VLUs and MLUs was considered 'very satisfactory' in 98% of cases and 'satisfactory' in 2% by the healthcare professionals involved in this study.
CONCLUSION: The association of multicomponent reduced compression treatment and TLC-NOSF dressings resulted in high rates of wound healing, leg oedema resolution, good adherence and tolerance. These findings support the use of the evaluated strategy in patients with VLUs or MLUs. Multicomponent reduced compression therapy could facilitate the early implementation of effective compression therapy in patients who are unable to tolerate strong compression or for whom it is contraindicated.
PMID:41528791 | DOI:10.12968/jowc.2025.0535