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November 1, 2025

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

W. H. Cole Marissa Carter Caroline Fife Marissa Docter

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Key Points

The aim is to assess the effectiveness of amniotic tissue grafts in treating chronic wounds, specifically diabetic foot and venous leg ulcers.
Multicenter hybrid platform trial design
Evaluation of amniotic tissue grafts
Focus on real-world applications and patient-centered care
Anticipated improvements in healing rates for diabetic foot ulcers
Potential benefits in the management of venous leg ulcers
Real-world applicability of advanced wound care strategies

Implication

A multicenter trial evaluates advanced wound care therapies in chronic ulcers, suggesting effective real-world applications.

Abstract

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

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Cite This Study

Cole et al. (2025) studied this question.

synapsesocial.com/papers/69eb0b25553a5433e34b4f72 https://doi.org/10.25270/wnds/25095

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Keep reading

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1Retrospective Evaluation of Human Amniotic Allografts for Diabetic Foot Ulcers and Venous Leg Ulcers Treated by an In-Home Mobile Wound Clinic2025
2A retrospective real-world analysis of placental-based allografts on pressure ulcersCohort Study · 2026
3Full thickness placental membrane allograft for diabetic foot ulcers: two clinical cases from the TIGERCAMP clinical trial2025
4Assessing the Outcomes and Complications of Skin Allografts in Healing Diabetic Foot and Venous Leg Ulcers: A Systematic Review of Randomised Controlled TrialsHuman Clinical Trial · 2026
5A multicenter, prospective randomized controlled modified dual platform trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers (TIGERCAMP)2025 · 1 citations

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"A Small WIN: A Case Series on Amniotic Grafting for Wound Healing and the importance of Good Standard of Care"2024
A novel approach for the treatment of diabetic foot ulcers using a multimodal wound matrix: a clinical study2024
Use of amniotic membrane in hard-to-heal wounds: a multicentre retrospective study2024