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. Plain Language Summary: Diabetic foot ulcers are open wounds on the foot that can last for months and can affect far more than the skin. They can make walking harder, limit daily activities, increase anxiety, and require repeated clinic visits and dressing changes. Because of this, it is important to measure not only whether a wound becomes smaller, but also whether people feel and function better during treatment. We followed 28 adults with diabetic foot ulcers who were treated with 2 silicone dressings designed to absorb wound fluid and protect the surrounding skin. Patients were observed for up to 6 weeks and were also asked to complete questionnaires about quality of life and perceived treatment benefit. Most wounds improved during follow-up. Around 78% to 86% of patients achieved at least a 20% reduction in wound area, depending on whether the wound was measured before or after cleansing and debridement, and about 1 in 5 ulcers healed completely. Patients also reported meaningful improvements in wound-related quality of life, especially in emotional well-being and everyday life. Perceived treatment benefit also improved. Physical activity remained broadly stable, patients followed offloading recommendations closely, and no dressing-related safety concerns were identified. These findings suggest that silicone superabsorbent polymer dressings may support both wound improvement and patient well-being. Future studies should test these results against comparator dressings and should also measure costs and resource use so that the full value of treatment can be evaluated. Keywords: diabetic foot ulcer, patient-reported outcomes, quality of life, wound healing, superabsorbent dressing, outcomes research
Armstrong et al. (Mon,) studied this question.