Use of Santyl Within an Accountable Care Organization

NCT02716519 | Withdrawn Phase 4

• 1 other identifier: 017-101-09-037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer; Foot Ulcer, Diabetic

Keywords

Diabetes; diabetic foot ulcer; foot sore; type 2 diabetes; type 1 diabetes; DFU; pressure ulcers; bed sores

Outcome Measures

Primary Outcomes (1)

• Target Ulcer Complications

  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

  12 months

Secondary Outcomes (20)

• The incidence of increase in ulcer size by more than 25% between treatment groups during the assessment period

  12 months

• The incidence of cellulitis between treatment groups during the assessment period

  12 months

• The incidence of ulcer infections between treatment groups during the assessment period

  12 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 Arms (2)

Santyl

EXPERIMENTAL

Collagenase ointment applied topically once per day for up to six weeks

Biological: Santyl

Standard Card

ACTIVE COMPARATOR

Standard Care not specified by the protocol; Investigators choose the appropriate standard care treatment for each participant

Other: Standard Care

Interventions

Santyl BIOLOGICAL

Collagenase ointment applied topically once per day for up to six weeks

Santyl

Standard Care OTHER

Standard Care not specified by the protocol; Investigators choose the appropriate standard care treatment for each participant

Standard Card

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
• Eighteen (18) years of age or older, of either sex, and of any race or skin type.
• Willing and able to make all required study visits.
• Able to follow instructions and perform the dressing changes at home or have a caregiver who can perform the dressing changes according to the protocol.
• Subject is currently being treated in an in-patient acute care setting.
• Willing to use an appropriate off-loading device to keep weight off of foot ulcers; currently receiving adequate pressure redistribution according to local protocol in the affected area for pressure ulcers.
• For DFU: An ulcer present on any part of the plantar surface of the foot or plantar surface of the hallux which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit using the ARANZ Silhouette imaging device).
• For PU: Stage II-IV ulcer that is 1 cm2 to 64 cm2 inclusive (as measured at the Screening Visit using the ARANZ Silhouette imaging device).
• \- Subjects may have more than one ulcer without limitation on the ulcer burden, but only one qualifying ulcer per subject will be selected for the study (selection based on greatest clinical need, as determined by the Investigator).
• For lower extremity ulcers: Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of \> 0.70 and ≤ 1.2. If ABI \> 1.2, perfusion at or near the site of the ulcer must be confirmed: i.e., the foot is warm to the touch and has palpable pulses. Availability of an ABI completed within the 90 days of Screening is acceptable.
• Separation of at least 5 cm (closest ulcer edge to other closest ulcer edge) as measured using the ARANZ Silhouette imaging device if ≥ 2 ulcers are present.
• Target ulcer is not infected based on clinical assessment.

You may not qualify if:

• Contraindications or hypersensitivity to the use of clostridial collagenase.
• Participation in another clinical trial within thirty (30) days of Screening, or planned participation overlapping with this study.
• Bleeding disorder that would preclude sharp debridement during the study.
• Active cellulitis of the target ulcer, lymphangitic streaking, deep tissue abscess, or infection of muscle, tendon, joint or bone.
• Co-morbidities leading to systemic organ dysfunction or severe single- or multi-organ failure that in the opinion of the Investigator would preclude safe subject participation in the study.
• A target ulcer which involves the underlying tissues of tendon.
• Diagnosis of chronic granulomatous disease, leukocyte adhesion defects, or severe neutropenia.
• Current treatment (at the time of the Screening Visit) with any of the following:
• Systemic corticosteroids. If corticosteroid treatment was for ≥ 10 days, there must be a 1 week interval between discontinuation and screening.
• Immunosuppressive agents
• Chemotherapeutic agents
• Antiviral agents
• Systemic antibiotic therapy for acute wound-related infection
• Topical antibiotic treatment of the target ulcer
• Treatment of target ulcer with bioactive therapies within 1 month of screening:

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 16066, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Diabetic Foot; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Interventions

Collagenases; Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jaime E Dickerson, PhD

  Smith & Nephew, Inc.

  STUDY CHAIR

• Sandeep Kathju, MD/PhD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 23, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)