Journal of wound care · 2025
Use of Relese in the treatment of hard-to-heal ulcers: a retrospective, multicentre real-world study.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Freeland Katherine W, Ramirez Matt D, Wakelee Ashley M
Аннотация
OBJECTIVE: To describe real-world outcomes and safety associated with Relese (StimLabs, US), a fenestrated dehydrated complete human placental membrane (dCHPM), as an adjunct to standard of care (SoC) for hard-to-heal (chronic) ulcers.
METHOD: A retrospective observational audit of adults with ulcers of ≥4 weeks' duration, despite SoC, treated with the dCHPM at three US centres from May 2023 to April 2025. Outcomes were summarised descriptively and included: complete closure rate; time to closure; closure category; percentage area reduction (PAR); and number of applications to closure. Safety outcomes included wound-related adverse events (AEs), amputation and mortality.
RESULTS: A total of 23 patients with 26 ulcers (42% diabetic foot ulcers; 46% neuropathic; 12% other) were included. In the intent-to-treat (ITT) population, 54% of ulcers achieved complete closure; in the per-protocol (PP) population, 78% closed. Median time to closure was 49 days, with a median of 5.5 applications. At week 12, mean PAR was 56% in the ITT population (77% ≥50% PAR) and 86% in the PP population (100% ≥50% PAR). AEs occurred in 30% of patients, most commonly, local infection (26%) and inflammation (13%). In addition, one amputation and two hospitalisations occurred, none of which were considered related to use of the dCHPM. No serious AEs related to the dCHPM were reported.
CONCLUSION: In this audit, the dCHPM was associated with timely closure and favourable safety outcomes in real-world practice. These descriptive findings may contribute to the growing body of real-world evidence supporting full-thickness placental membranes as adjuncts to SoC in the treatment of hard-to-heal ulcers.
METHOD: A retrospective observational audit of adults with ulcers of ≥4 weeks' duration, despite SoC, treated with the dCHPM at three US centres from May 2023 to April 2025. Outcomes were summarised descriptively and included: complete closure rate; time to closure; closure category; percentage area reduction (PAR); and number of applications to closure. Safety outcomes included wound-related adverse events (AEs), amputation and mortality.
RESULTS: A total of 23 patients with 26 ulcers (42% diabetic foot ulcers; 46% neuropathic; 12% other) were included. In the intent-to-treat (ITT) population, 54% of ulcers achieved complete closure; in the per-protocol (PP) population, 78% closed. Median time to closure was 49 days, with a median of 5.5 applications. At week 12, mean PAR was 56% in the ITT population (77% ≥50% PAR) and 86% in the PP population (100% ≥50% PAR). AEs occurred in 30% of patients, most commonly, local infection (26%) and inflammation (13%). In addition, one amputation and two hospitalisations occurred, none of which were considered related to use of the dCHPM. No serious AEs related to the dCHPM were reported.
CONCLUSION: In this audit, the dCHPM was associated with timely closure and favourable safety outcomes in real-world practice. These descriptive findings may contribute to the growing body of real-world evidence supporting full-thickness placental membranes as adjuncts to SoC in the treatment of hard-to-heal ulcers.