NCT04901013

Clinical Study Of Affinity Versus SOC In The Management Of VLUs

A Prospective, Multicenter, Randomized, Controlled Clinical Study Of Affinity Versus SOC In The Management Of VLUs

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs. Affinity® will be used along with standard of care on venous leg ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.

Detailed description

Two hundred (200) subjects with a chronic VLU ranging in size from 2cm2 and 80 cm2 will be randomized 1:1 to either Affinity® and SOC or SOC alone following the 28 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure. Subjects that are randomized into the SOC group whose VLU has not healed by week 12 may be crossed over to receive Affinity® and followed for an additional 12-14 weeks.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
OTHER	Affinity	Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM).

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2021-05-25
• Last updated: 2021-09-08

Locations

1 site across 1 country: United States