Use of Santyl Within an Accountable Care Organization
- Conditions
- Pressure UlcerFoot Ulcer, Diabetic
- Interventions
- Biological: SantylOther: Standard Care
- Registration Number
- NCT02716519
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Santyl Santyl Collagenase ointment applied topically once per day for up to six weeks Standard Card Standard Care Standard Care not specified by the protocol; Investigators choose the appropriate standard care treatment for each participant
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method The incidence of cellulitis between treatment groups during the assessment period 12 months During the post-acute phase, weekly patient and caregiver time for target ulcer treatment 6 months Emergency department visits for target ulcer treatment 12 months During the acute phase, daily time at bedside for target ulcer treatment 6 months The incidence of ulcer infections between treatment groups during the assessment period 12 months Hospital readmission for target ulcer treatment 12 months During the post-acute phase, weekly clinician time at bedside for target ulcer treatment 12 months The incidence of increase in ulcer size by more than 25% between treatment groups during the assessment period 12 months Percentage change in ulcer area from baseline to the end of treatment period 12 months During the acute phase, daily lab tests for target ulcer treatment 6 months The incidence of osteomyelitis between treatment groups during the assessment period 12 months The incidence of requirement for surgical intervention between treatment groups during the assessment period 12 months Study discontinuations (target ulcer related) 12 months During the acute phase, daily wound care products (including dressings) for target ulcer treatment 6 months During the acute phase, the quantity of daily wound care products (including dressings) for target ulcer treatment will be collected. At the conclusion of the study, the wound care products used will be costed using national costing averages. Total costs will be aggregated on a per patient basis and then compared between the standard of care group and the Santyl group.
During the post-acute phase, weekly wound care products (including dressings) for target ulcer treatment 6 months During the post-acute phase, weekly antibiotics and analgesics used for target ulcer treatment 6 months During the acute phase, daily antibiotics and analgesics used for target ulcer treatment 6 months During the acute phase, daily surgical procedures for target ulcer treatment 6 months During the post-acute phase, weekly surgical procedures for target ulcer treatment 6 months During the post-acute phase, weekly lab tests for target ulcer treatment 6 months
Trial Locations
- Locations (1)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States