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Войти в исследования Medical devices (Auckland, N.Z.) · 2026
Patient-Reported Outcomes and Wound-Related Quality of Life in Adults with Diabetic Foot Ulcers Treated with Silicone Superabsorbent Polymer Dressings: Exploratory Results from a Prospective Multicenter Nonrandomized Cohort Study.
СтатьяНазвание и аннотация: Перевод в очереди
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Armstrong David G, Mikosinski Jacek, Panczak Konrad, Wegrzynowski Adam, Piechota Dorota, Kotala Marek, Lipinski Przemyslaw, Rybolowicz Katarzyna, Lipinska Agnieszka, Velickovic Vladica, Bil Jacek, Szenk Teresa, Buczak Patrycja, Pitchika Anitha, Probst Sebastian
Аннотация
BACKGROUND: Diabetic foot ulcers (DFUs) are associated with substantial clinical and economic burden and impaired health-related quality of life (HRQoL). Although wound healing remains a core endpoint, recent consensus work identifies HRQoL as an essential outcome in DFU studies. This study describes wound healing, patient-reported outcomes, function, and safety in adults with DFU treated with silicone superabsorbent polymer (SAP) dressings.
METHODS: This exploratory prospective, multicenter, nonrandomized cohort study reports the DFU subgroup from a broader single-arm investigation conducted at eight specialist centers in Poland. Adults with superficial, noninfected DFUs received silicone SAP dressings for up to 6 weeks with standard offloading. Prespecified patient-reported outcome measures were the Patient Benefit Index for wounds (PBI-W) and the Wound Quality of Life questionnaire (Wound-QoL-17). Additional endpoints included wound area reduction (centralized digital planimetry), complete epithelialization, accelerometry-based activity, offloading adherence, and safety.
RESULTS: Twenty-eight participants were included (75.0% male; mean age, 63.4 years), with a median wound duration of 166 days. By the final visit, 21 (77.8%) achieved at least 20% wound area reduction before cleansing/debridement and 24 (85.7%) after cleansing/debridement; 6 (22.2%) achieved complete epithelialization. Mean global Wound-QoL improved from 2.4 ± 0.6 to 1.5 ± 1.0 (mean change, -1.0 ± 0.8; P < 0.001), with greatest improvements in psyche and everyday-life domains. Mean PBI-W increased from 2.44 ± 0.94 to 2.94 ± 0.87 (mean change, 0.45 ± 1.10; P = 0.043). Activity intensity remained stable, offloading adherence exceeded 95%, and no device-related adverse events were reported.
CONCLUSION: In this prospective DFU cohort, use of silicone SAP dressings within a structured care setting was associated with improvements in wound area reduction and wound-related quality of life over 6 weeks. These results highlight the feasibility of integrating patient-reported outcomes in DFU studies and provide a clinically relevant platform for future comparative and health-economic evaluations.
METHODS: This exploratory prospective, multicenter, nonrandomized cohort study reports the DFU subgroup from a broader single-arm investigation conducted at eight specialist centers in Poland. Adults with superficial, noninfected DFUs received silicone SAP dressings for up to 6 weeks with standard offloading. Prespecified patient-reported outcome measures were the Patient Benefit Index for wounds (PBI-W) and the Wound Quality of Life questionnaire (Wound-QoL-17). Additional endpoints included wound area reduction (centralized digital planimetry), complete epithelialization, accelerometry-based activity, offloading adherence, and safety.
RESULTS: Twenty-eight participants were included (75.0% male; mean age, 63.4 years), with a median wound duration of 166 days. By the final visit, 21 (77.8%) achieved at least 20% wound area reduction before cleansing/debridement and 24 (85.7%) after cleansing/debridement; 6 (22.2%) achieved complete epithelialization. Mean global Wound-QoL improved from 2.4 ± 0.6 to 1.5 ± 1.0 (mean change, -1.0 ± 0.8; P < 0.001), with greatest improvements in psyche and everyday-life domains. Mean PBI-W increased from 2.44 ± 0.94 to 2.94 ± 0.87 (mean change, 0.45 ± 1.10; P = 0.043). Activity intensity remained stable, offloading adherence exceeded 95%, and no device-related adverse events were reported.
CONCLUSION: In this prospective DFU cohort, use of silicone SAP dressings within a structured care setting was associated with improvements in wound area reduction and wound-related quality of life over 6 weeks. These results highlight the feasibility of integrating patient-reported outcomes in DFU studies and provide a clinically relevant platform for future comparative and health-economic evaluations.