NCT02716519

Use of Santyl Within an Accountable Care Organization

Clinical Outcomes for Chronic Ulcers Treated With Clostridial Collagenase (SANTYL®) Versus Standard Care Within the Continuum of Care of an Accountable Care Organization (ACO)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the comparative effectiveness of SANTYL® versus standard of care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of care of an ACO. After meeting study criteria, participants will be randomly assigned to apply Santyl or standard care to their pressure ulcer or diabetic foot ulcer for up to 6 weeks. Participants will be followed for one year from the date of randomization to assess ulcer status and ulcer complications.

Conditions

• Pressure Ulcer
• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
BIOLOGICAL	Santyl	Collagenase ointment applied topically once per day for up to six weeks
OTHER	Standard Care	Standard Care not specified by the protocol; Investigators choose the appropriate standard care treatment for each participant

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-03-23
• Last updated: 2017-03-15

Locations

1 site across 1 country: United States