NCT03855514

Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers

A Prospective, Multicenter, Randomized, Controlled Clinical Study Of NuShield® and Standard of Care (SOC) Compared to SOC Alone For The Management Of Diabetic Foot Ulcers

• 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 NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy.

Detailed description

Two hundred (200) subjects with a chronic DFU ranging in size from 0.5cm2 and 25 cm2 will be randomized 1:1 to either NuShield® and SOC or SOC alone following the 14 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 DFU has not healed by week 12 may be crossed over to receive NuShield® and followed for an additional 12-14 weeks.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	NuShield	NuShield® is a dehydrated placental allograft.

Timeline

• Start date: 2019-02-08
• Primary completion: 2021-11-01
• Completion: 2021-12-30
• First posted: 2019-02-26
• Last updated: 2021-05-26

Locations

9 sites across 1 country: United States