NCT01835379

Study of Oasis Ultra in Diabetic Foot Ulcers

A Randomized, Open Label Controlled Trial of OASIS® Ultra Tri-Layer Matrix Compared to Standard Care in the Healing of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Oasis	Oasis Ultra will be applied once per week for up to 12 weeks.
OTHER	Standard

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-04-18
• Last updated: 2015-01-22
• Results posted: 2015-01-22

Locations

16 sites across 1 country: United States