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

NCT02716519 Phase 4 WITHDRAWN

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.

Details

Lead sponsor	Smith & Nephew, Inc.
Phase	Phase 4
Status	WITHDRAWN
Start date	2016-08
Completion	2018-12

Conditions

• Pressure Ulcer
• Foot Ulcer, Diabetic

Interventions

• Santyl
• Standard Care

Primary outcomes

• Target Ulcer Complications — 12 months
  Target ulcer complications from baseline to the end of the assessment period in each treatment group: * increase in size by more than 25%, * cellulitis, * ulcer infections, * osteomyelitis, * requirement for surgical intervention

Countries

United States