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Pressure UlcerPhase 4NCT02716519

Use of Santyl Within an Accountable Care Organization

A Phase 4 study testing Santyl in people with Pressure Ulcer and Foot Ulcer, Diabetic, run by Smith & Nephew, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pressure Ulcer, Foot Ulcer, Diabetic
What is being tested?
Santyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2016to Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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:
  • Platelet-derived growth factor (e.g., Regranex)
  • Cellular or Tissue-based Products (e.g., Apligraf, Dermagraft, Integra, Oasis, etc.)
  • Amniotic membrane products (e.g., EpiFix, Grafix, etc.)
  • Prior treatment of target ulcer for any length of time with CCO (SANTYL) within 30 days of screening.
  • Any prior radiation therapy to the affected area
  • Medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
  • Blood counts and blood chemistry values as follows:
  • NOTE: Availability of lab results within the 30 days of Screening is acceptable.
  • Alanine aminotransferase (ALT) > 3x upper limit of normal
  • Aspartate aminotransferase (AST) > 3x upper limit of normal
  • Gamma Glutamyl Transferase (GGT) > 2.5x upper limit of normal
  • Serum albumin < 2.0 g/dL
  • Pre-albumin levels of < 10 mg/dL
  • Alkaline phosphatase > 500 U/L
  • Serum total bilirubin > 3.0 mg/dL
  • Serum BUN > 75 mg/dL
  • Serum creatinine > 4.5 mg/dL
  • HbA1c > 12%
  • Hemoglobin (Hgb) < 8.0 g/dL
  • WBC < 2.0 x 109/L
  • Absolute neutrophil count < 1.0 x 109/L
  • Platelet count < 50 x 109/L

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 16066

Other trials in United States

About this study

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

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.

Being tested
Santyl, Standard Care
Keywords
Diabetes, diabetic foot ulcer, foot sore, type 2 diabetes, type 1 diabetes, DFU, pressure ulcers, bed sores
Medical subject headings
Pressure Ulcer, Diabetic Foot, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SantylBiological

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

  • Standard CareOther

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

Study groups in NCT02716519
Study groupRoleWhat they receive
SantylExperimentalCollagenase ointment applied topically once per day for up to six weeks
Receives: Biological: Santyl
Standard CardActive comparatorStandard Care not specified by the protocol; Investigators choose the appropriate standard care treatment for each participant
Receives: Other: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (20)

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

    Measured: 12 months

  2. The incidence of cellulitis between treatment groups during the assessment period

    Measured: 12 months

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

    Measured: 12 months

  4. The incidence of osteomyelitis between treatment groups during the assessment period

    Measured: 12 months

  5. The incidence of requirement for surgical intervention between treatment groups during the assessment period

    Measured: 12 months

  6. Percentage change in ulcer area from baseline to the end of treatment period

    Measured: 12 months

  7. Study discontinuations (target ulcer related)

    Measured: 12 months

  8. Hospital readmission for target ulcer treatment

    Measured: 12 months

  9. Emergency department visits for target ulcer treatment

    Measured: 12 months

  10. During the acute phase, daily time at bedside for target ulcer treatment

    Measured: 6 months

  11. During the acute phase, daily wound care products (including dressings) for target ulcer treatment

    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.

    Measured: 6 months

  12. During the acute phase, daily antibiotics and analgesics used for target ulcer treatment

    Measured: 6 months

  13. During the acute phase, daily lab tests for target ulcer treatment

    Measured: 6 months

  14. During the acute phase, daily surgical procedures for target ulcer treatment

    Measured: 6 months

  15. During the post-acute phase, weekly clinician time at bedside for target ulcer treatment

    Measured: 12 months

  16. During the post-acute phase, weekly patient and caregiver time for target ulcer treatment

    Measured: 6 months

  17. During the post-acute phase, weekly wound care products (including dressings) for target ulcer treatment

    Measured: 6 months

  18. During the post-acute phase, weekly antibiotics and analgesics used for target ulcer treatment

    Measured: 6 months

  19. During the post-acute phase, weekly lab tests for target ulcer treatment

    Measured: 6 months

  20. During the post-acute phase, weekly surgical procedures for target ulcer treatment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716519
Sponsor's protocol ID
017-101-09-037
Status last verified
Mar 2017
First submitted
2 Mar 2016
Last updated
15 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Santyl in people with Pressure Ulcer and Foot Ulcer, Diabetic, run by Smith & Nephew, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Ulcer Complications (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.

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