A multicenter hybrid platform trial evaluating amniotic tissue grafts in chronic wounds: a real-world evidence protocol for diabetic foot and venous leg ulcers.

BACKGROUND

Traditional randomized controlled trials of efficacy often lack generalizability due to strict inclusion criteria and controlled environments. Real-world evidence trials offer a complementary approach by evaluating the effectiveness of interventions in routine clinical practice.

OBJECTIVE

To prospectively assess the effectiveness of trilayer and single-layer amniotic tissue grafts in treating diabetic foot ulcers and venous leg ulcers using a hybrid platform design compared with historical controls.

METHODS

This multicenter, umbrella design study includes 2 parallel prospective cohorts with 2 intervention arms each and a shared retrospective standard of care control group. Subjects will be randomized to receive either intervention product 1 or intervention product 2 in addition to standard of care. Retrospective controls will be selected from the US Wound Registry using coarsened exact matching, comparing the primary end point of complete wound closure at 12 weeks and the secondary end point of wound area reduction. Change in quality of life as assessed using a patient-reported outcome measure and pain scores will be evaluated in the subjects in the prospective arm.

CONCLUSION

This protocol outlines a pragmatic, patient-centered approach to evaluating advanced wound care therapies in real-world settings.