Long-term effects of Dermagold100® therapy in lipedema and lymphedema treatment: A 5-year prospective longitudinal study

Purpose To evaluate the 5-year efficacy and safety of Dermagold100®, an extracorporeal shock wave therapy (ESWT) system, combined with Complex Decongestive Therapy (CDT) compared with CDT alone in patients with advanced lipedema and lymphedema, and to assess quality of life and predictors of response. Methods This 5-year prospective longitudinal controlled study was conducted from October 2020 to November 2025 and included 150 patients with stage II–III lipedema or lymphedema. Participants received Dermagold100® plus CDT ( n = 100) or CDT alone ( n = 50). ESWT was administered twice weekly for 12 weeks using standardized parameters. Outcomes included limb volume, bioimpedance ratio, tissue stiffness, pain, quality of life, and functional capacity over 60 months. Mixed-model repeated-measures analysis was performed, with p < .05 considered significant. Results At 60 months, the intervention group showed significantly greater limb volume reduction (32.7% vs 16.1%, p < .001), improved bioimpedance normalization, and marked fibrosis reduction (12.3 vs 19.8 kPa). Pain reduction, quality of life, and functional outcomes were significantly better in the intervention group. Treatment effects were consistent across subgroups. Adverse events were mild and occurred in 4.8% of sessions. Conclusions Dermagold100® combined with CDT provides sustained, clinically meaningful improvements with a favorable safety profile, supporting its role as an effective long-term multimodal therapy for advanced lymphatic disorders.