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Use of Santyl Within an Accountable Care Organization

NCT02716519 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-03-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Jaime E Dickerson, PhD · Smith & Nephew, Inc.

  • Sandeep Kathju, MD/PhD · University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716519 on ClinicalTrials.gov