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Pressure UlcerPhase 4NCT02718625

Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, participants will be randomly assigned for application of SANTYL® or SoloSite® to their pressure ulcer for up to 6 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pressure Ulcer
What is being tested?
Santyl and SoloSite®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Aug 2016to 9 Mar 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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.
  • Willing to comply with protocol instructions, including allowing all study assessments.
  • Subject is in-patient in a long-term care facility.
  • A pressure ulcer present with a surface area ≥ 1.0 cm2 and ≤ 64.0 cm2 confirmed using the ImageIQ EDCIQ mobile imaging system. Only one qualifying ulcer per subject will be selected for the study (selection based on greatest clinical need, as assessed by the Investigator).
  • The target ulcer must present with ≥85% necrotic, nonviable tissue as assessed by two independent image reviewers.
Show all 14Show fewer
  • The target ulcer has not been previously treated with hydrogel (SoloSite®) or with SANTYL®. Prior ulcers at or near the same location may have been treated with these products.
  • No current infections requiring treatment with antibiotics (antibiotic use is permitted for the purpose of urinary tract infection prophylaxis, but this must be explicitly stated in the subject's chart).
  • Acceptable state of health and nutrition with pre-albumin levels of ≥ 10 mg/dL (0.10 g/L), per the Screening local lab report. This is not required if a pre-albumin test within range has been conducted within the last 30 days.
  • A hemoglobin A1c < 7.9% per the Screening local lab report. This is not required if a hemoglobin A1c test within range has been conducted within the last 30 days.
  • Have adequate pressure redistribution to the affected area or off-loading if the ulcer is on a lower extremity.
  • No known allergies or sensitivities to either test article or the dressings.
  • Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal), may participate in the study if they meet the following condition:
  • -A negative urine pregnancy test at screening

Who cannot join

  • Undergoing therapy with another investigational agent within thirty (30) days of Study Visit 1, or planned participation overlapping with this study.
  • Current oral steroid treatment with a daily dose exceeding 5 mg.
  • Inability to comply with off-loading.
  • If the ulcer is on a lower extremity, inadequate arterial blood flow to the affected limb as evidenced by an ankle brachial index (ABI) <0.85.
  • Presence of callus requiring surgical debridement within 3 days of Study Visit 1.
  • Target ulcer with exposure of tendon, muscle or bone.
  • Medical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Lee's Summit, Missouri, 64086

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of Enzymatic Debridement of Pressure Ulcers With Clostridial Collagenase Ointment (SANTYL®) or Hydrogel (SoloSite®)

This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, participants will be randomly assigned for application of SANTYL® or SoloSite® to their pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term care setting, the removal of dead skin (debridement) with SANTYL® resulted in more participants achieving complete debridement, more rapidly than when SoloSite® is used. The goal of the present study is to confirm the results of the earlier study, demonstrating superior debridement outcomes for pressure ulcers of patients in long-term care as compared to ulcers managed with SoloSite®.

Conditions
Pressure Ulcer
Being tested
Santyl, SoloSite®
Keywords
Pressure Ulcers, Bed sores, Long-term care, Nursing home
Medical subject headings
Pressure Ulcer

What participants receive

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

  • SantylBiological

    Collagenase ointment applied topically

  • SoloSite®Biological

    SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.

Study groups in NCT02718625
Study groupRoleWhat they receive
SantylExperimentalSantyl collagenase ointment applied topically once per day for up to six weeks
Receives: Biological: Santyl
SoloSite®Active comparatorSOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
Receives: Biological: SoloSite®

What is being measured

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

  1. Proportion of Ulcers With Complete Debridement

    For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.

    Measured: 6 weeks

Secondary outcomes (5)

  1. Time in Days to Complete Debridement

    For purposes of this secondary analysis, the time (in days) to achieve complete debridement (as defined in the primary analysis) was to be calculated from the date of randomization visit to the date of which the subject's ulcer was deemed to have achieved complete debridement.

    Measured: 6 weeks

  2. Percentage Reduction in Non-viable Tissue

    For purposes of this secondary analysis, the assessment of percentage of non-viable necrotic tissue was to be assessed based on photograph review by two independent reviewers, with the reduction calculated as: percentage of non-viable necrotic tissue at Visit 1 - percentage of non-viable necrotic tissue at Visit 7.

    Measured: 6 weeks

  3. Percentage Reduction in Ulcer Area

    For purposes of this secondary analysis, the percentage reduction in ulcer area was to be measured during ulcer photograph review by two independent reviewers, using the ImageIQ EDCIQ mobile imaging system, with the reduction calculated as: ([ulcer area at Visit 1 - ulcer area at Visit 7 / ulcer area at Visit 1] x 100).

    Measured: 6 weeks

  4. Pressure Ulcer Scale for Healing (PUSH) Score

    For purposes of this secondary analysis, changes in wound status were to be measured by using the Pressure Ulcer Scale for Healing (PUSH) Tool. At Visits 1 and 7, the target ulcer was to be scored based on length/width (from 0 cm^2 to >24 cm^2 on a scale of 1 to 10), exudate amount (from 'none' to 'heavy' on a scale of 0 to 3) , and tissue type ('closed' to 'necrotic tissue' on a scale of 0 to 4); from which a total PUSH score from the sum of scores for the three categories could be derived (ranging from 0 to 17). Higher scores indicated a worse response. The reduction in PUSH individual sub-scores and total PUSH scores were calculated as: (PUSH Score at Visit 1 - Push Score at Visit 7/Exit).

    Measured: 6 weeks

  5. Wound Bed Sore (WBS) Score

    For purposes of this secondary analysis, changes in wound status were to be measured by using the Wound Bed Sore (WBS) score. At Visits 1 and 7, eight individual wound bed sore characteristics were scored, each on a scale of 0 to 2 (higher scores represented better outcomes), and then summed to derive the total WBS score (ranging from 0 to 16). The reduction in total WBS scores were calculated as: (Total WBS Score at Visit 1 - Total WBS Score at Visit 7/Exit).

    Measured: 6 weeks

Timeline

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

  1. First posted24 Mar 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion9 Mar 2017
  4. Study completion9 Mar 2017

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718625
Sponsor's protocol ID
017-101-09-036
Status last verified
Feb 2020
First submitted
18 Mar 2016
Last updated
10 Mar 2020
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Santyl and SoloSite® in people with Pressure Ulcer, 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 14 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 Mar 2020. 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?

Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Ulcers With Complete Debridement (time frame: 6 weeks). 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 NCT02718625.

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 10 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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