PATIENT-REPORTED OUTCOMES AND WOUND-SPECIFIC QUALITY OF LIFE IN DIABETIC FOOT ULCERS AND VENOUS LEG ULCERS: A PROSPECTIVE SINGLE-ARM STUDY OF SILICONE SUPERABSORBENT POLYMER DRESSINGS
Author(s)
Teresa Szenk, MSc1, Agnieszka Segiet-Swiecicka, MSc2, Vladica M. Velickovic, PhD, MD3, Anitha Pitchika, PhD4, Sebastian Probst, PhD5, David G. Armstrong, PhD, MD6;
1Clean Data Labs, Warshaw, Poland, 2Clean Data Labs, Warsaw, Poland, 3Hartmann group, Evidence Generation Department, Neu-Ulm, Germany, 4HARTMANN GROUP, Evidence Generation Department, Los Angeles, CA, USA, 5HES-SO, Geneva, Switzerland, 6Keck School of Medicine of University of Southern California, Los Angeles, CA, USA
1Clean Data Labs, Warshaw, Poland, 2Clean Data Labs, Warsaw, Poland, 3Hartmann group, Evidence Generation Department, Neu-Ulm, Germany, 4HARTMANN GROUP, Evidence Generation Department, Los Angeles, CA, USA, 5HES-SO, Geneva, Switzerland, 6Keck School of Medicine of University of Southern California, Los Angeles, CA, USA
OBJECTIVES: To evaluate changes in patient-reported benefit and wound-specific quality of life among patients with venous leg ulcers (VLU) or diabetic foot ulcers (DFU) managed with silicone superabsorbent polymer (SAP) dressings over 6 weeks, and to characterize perceived social support in this population.
METHODS: This prospective, multicenter, single-arm study enrolled 80 patients with VLU or DFU. Participants received silicone or silicone border SAP dressings combined with compression therapy (VLU) or offloading boots (DFU). Patient-reported outcomes were assessed using the Patient Benefit Index for Wounds (PBI-W) and Wound Quality of Life questionnaire (Wound-QoL) at baseline and week 6. Perceived social support was measured once using the Social Support Questionnaire (SSQ), primarily at baseline. Within-patient changes from baseline were evaluated, and Wound-QoL improvements were interpreted against the published minimal important difference (MID) of 0.5 points.
RESULTS: Global PBI-W scores improved significantly from baseline to week 6 (n=72), increasing from mean (SD) 2.26 (1.05) to 2.90 (0.94); mean change 0.57 (1.18), p<0.001. Wound-QoL global scores decreased from 2.2 (0.8) to 1.3 (0.9); mean reduction 0.9 (1.0), p<0.001 (n=75). Mean subscale reductions were: body 0.6 (0.9), psyche 0.9 (1.4), and everyday life 0.9 (1.2); all p<0.001. All Wound-QoL improvements exceeded the MID, indicating patient-relevant change. SSQ total scores indicated high perceived social support (n=77; mean 6.1), with comparable domain scores: significant other 6.4, family 6.2, and friends 5.7.
CONCLUSIONS: Management with silicone SAP dressings alongside standard adjunctive care was associated with clinically meaningful improvements in patient-reported benefit and wound-specific quality of life among VLU/DFU patients, within a context of strong social support. Controlled comparative studies are needed to quantify incremental treatment effects and generate utility inputs for economic evaluation.
METHODS: This prospective, multicenter, single-arm study enrolled 80 patients with VLU or DFU. Participants received silicone or silicone border SAP dressings combined with compression therapy (VLU) or offloading boots (DFU). Patient-reported outcomes were assessed using the Patient Benefit Index for Wounds (PBI-W) and Wound Quality of Life questionnaire (Wound-QoL) at baseline and week 6. Perceived social support was measured once using the Social Support Questionnaire (SSQ), primarily at baseline. Within-patient changes from baseline were evaluated, and Wound-QoL improvements were interpreted against the published minimal important difference (MID) of 0.5 points.
RESULTS: Global PBI-W scores improved significantly from baseline to week 6 (n=72), increasing from mean (SD) 2.26 (1.05) to 2.90 (0.94); mean change 0.57 (1.18), p<0.001. Wound-QoL global scores decreased from 2.2 (0.8) to 1.3 (0.9); mean reduction 0.9 (1.0), p<0.001 (n=75). Mean subscale reductions were: body 0.6 (0.9), psyche 0.9 (1.4), and everyday life 0.9 (1.2); all p<0.001. All Wound-QoL improvements exceeded the MID, indicating patient-relevant change. SSQ total scores indicated high perceived social support (n=77; mean 6.1), with comparable domain scores: significant other 6.4, family 6.2, and friends 5.7.
CONCLUSIONS: Management with silicone SAP dressings alongside standard adjunctive care was associated with clinically meaningful improvements in patient-reported benefit and wound-specific quality of life among VLU/DFU patients, within a context of strong social support. Controlled comparative studies are needed to quantify incremental treatment effects and generate utility inputs for economic evaluation.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR164
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Geriatrics, SDC: Injury & Trauma, SDC: Sensory System Disorders (Ear, Eye, Dental, Skin), STA: Multiple/Other Specialized Treatments