Patient related outcome measures · 2026
Patient-reported outcomes in venous leg ulcers: results from a prospective multicenter single-arm cohort study of silicone superabsorbent polymer dressings.
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Probst Sebastian, Veličković Vladica, Mikosinski Jacek, Panczak Konrad, Wegrzynowski Adam, Piechota Dorota, Kotala Marek, Lipinski Przemyslaw, Rybolowicz Katarzyna, Lipinska Agnieszka, Bil Jacek, Szenk Teresa, Buczak Patrycja, Santoso Cornelia, Pitchika Anitha, Armstrong David G
Аннотация
BACKGROUND: Venous leg ulcers (VLUs) are chronic wounds associated with substantial symptom burden, impaired health-related quality of life, and high healthcare costs. Current guidance recommends assessing patient-centered outcomes alongside healing. This study reports the VLU subgroup of a prospective multicenter cohort, focusing on wound-related quality of life and patient-perceived treatment benefit.
METHODS: This prospective, single-arm cohort study was conducted in specialist wound centers in Poland. Adults with chronic, noninfected, exuding VLUs received RespoSorb Silicone Border or RespoSorb Silicone dressings together with standardized compression therapy for up to 6 weeks. Patient-reported outcomes (PRO) were the Wound Quality of Life questionnaire (Wound-QoL-17) and the Patient Benefit Index for wounds (PBI-W). Changes in Wound-QoL from baseline to final visit, responder analyses using the published 0.50-point minimal important difference and attained PBI-W scores at follow-up were analyzed.
RESULTS: Fifty-two patients with VLU were included (44.2% women; mean age 69.1 years). Final PRO data were available for 48 patients. Mean global Wound-QoL improved from 2.03 at baseline to 1.18 at final visit (mean change 0.81; 95% CI 0.49-1.12; p < 0.001; standardized response mean 0.74). Clinically meaningful improvement (≥0.50 points) occurred in 56.3% of patients. Final attained PBI-W benefit was high (mean 2.92 ± 0.97), with 93.8% achieving PBI-W ≥ 1 and 58.3% achieving PBI-W ≥ 3. No dressing-related serious adverse events were reported.
CONCLUSIONS: Silicone superabsorbent polymer dressings used with compression were associated with improved quality of life and high patient-perceived benefit. Findings support incorporating validated patient-reported outcomes in VLU research and warrant larger comparative studies.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT07549737 (Date of registration: 24.04.2026). Registration was completed retrospectively due to an administrative oversight during a transition in study leadership. The study protocol and prespecified study procedures were established before enrollment began, and the statistical analysis plan was finalized before database lock. No changes were made to the study objectives, endpoints, eligibility criteria, conduct, statistical analyses, or reporting as a result of the delayed registration.
METHODS: This prospective, single-arm cohort study was conducted in specialist wound centers in Poland. Adults with chronic, noninfected, exuding VLUs received RespoSorb Silicone Border or RespoSorb Silicone dressings together with standardized compression therapy for up to 6 weeks. Patient-reported outcomes (PRO) were the Wound Quality of Life questionnaire (Wound-QoL-17) and the Patient Benefit Index for wounds (PBI-W). Changes in Wound-QoL from baseline to final visit, responder analyses using the published 0.50-point minimal important difference and attained PBI-W scores at follow-up were analyzed.
RESULTS: Fifty-two patients with VLU were included (44.2% women; mean age 69.1 years). Final PRO data were available for 48 patients. Mean global Wound-QoL improved from 2.03 at baseline to 1.18 at final visit (mean change 0.81; 95% CI 0.49-1.12; p < 0.001; standardized response mean 0.74). Clinically meaningful improvement (≥0.50 points) occurred in 56.3% of patients. Final attained PBI-W benefit was high (mean 2.92 ± 0.97), with 93.8% achieving PBI-W ≥ 1 and 58.3% achieving PBI-W ≥ 3. No dressing-related serious adverse events were reported.
CONCLUSIONS: Silicone superabsorbent polymer dressings used with compression were associated with improved quality of life and high patient-perceived benefit. Findings support incorporating validated patient-reported outcomes in VLU research and warrant larger comparative studies.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT07549737 (Date of registration: 24.04.2026). Registration was completed retrospectively due to an administrative oversight during a transition in study leadership. The study protocol and prespecified study procedures were established before enrollment began, and the statistical analysis plan was finalized before database lock. No changes were made to the study objectives, endpoints, eligibility criteria, conduct, statistical analyses, or reporting as a result of the delayed registration.