Chronic Venous Leg UlcersPhase 4NCT02936128
TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers
A Phase 4 study testing TruSkin and Wound Cover in people with Chronic Venous Leg Ulcers, run by Osiris Therapeutics at 7 sites in United States.
Trial summary
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Venous Leg Ulcers
- What is being tested?
- TruSkin and Wound Cover
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2016to Apr 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 years and 80 years of age inclusive, as of the date of screening
- An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at the Screening Visit)
- Index Ulcer is located on the leg, below the knee
- The Index Ulcer is a Venous Leg Ulcer (VLU) greater than 10 cm2, inclusive, at the Screening Visit
- The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit
- The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
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- Wound is free of necrotic debris
- Patient has adequate circulation to the foot as documented by Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
- Confirmed diagnosis of venous insufficiency with duplex ultrasonography to demonstrate reflux of ≥ 0.5 seconds in the superficial lower extremity venous system.
Who cannot join
- Index Ulcer is of non-venous pathophysiology
- Gangrene is present on any part of the affected limb
- Patient is currently receiving dialysis or planning to go on dialysis
- Patient has a glycated hemoglobin A1c (HbA1c) level of >12%
- Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
- Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
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- Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
- Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
- Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
- Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
- Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
- Patient has active malignancy other than non-melanoma skin cancer
- Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
- Patient's random blood sugar is > 450 mg/dl at screening
- Patient is unable to receive compression therapy as a part of standard of care
- Patient has untreated alcohol or substance abuse at the time of screening
- Pregnant women and women who are breastfeeding
- Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
- Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
- Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
- Patients who have already been randomized in Protocol 352 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Study Visit
- Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
California City, California
Study site
Florida City, Florida
Study site
Massachusetts, Massachusetts
Study site
Michigan, Michigan
Study site
North Carolina, North Carolina
Study site
Pennsylvania, Pennsylvania
Study site
Virginia City, Virginia
About this study
Official title: A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.
- Conditions
- Chronic Venous Leg Ulcers
- Being tested
- TruSkin, Wound Cover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruSkinOther
Wound CoverOther
| Study group | Role | What they receive |
|---|---|---|
| TruSkin® | Experimental | Cryopreserved skin allograft Receives: Other: TruSkin |
| Wound Cover | Active comparator | Active Comparator for Venous Leg Ulcers Receives: Other: Wound Cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks
Measured: 8 weeks
Secondary outcomes (6)
Proportion of patients that achieve complete closure of the index wound by 12 weeks
Measured: 12 weeks
Proportion of patients that achieve a 50% or greater reduction in wound size by 4 weeks
Measured: 4 weeks
Time to initial wound closure
Measured: Up to 84 days
Number of product applications
Measured: Up to 84 days
Number of AEs
Measured: Up to 84 days
Number of patients with worsening of index wound defined by ≥ 50% increase in wound size
Measured: Up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Osiris decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osiris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936128
- Sponsor's protocol ID
- Osiris Protocol 352
- Status last verified
- Apr 2017
- First submitted
- 20 Sep 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02936128
- Acronym / sponsor ID
- Osiris Protocol 352
- Conditions
- Chronic Venous Leg Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Osiris decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Osiris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TruSkin® | Experimental | Other: TruSkinCryopreserved skin allograft |
| Wound Cover | Active comparator | Other: Wound CoverActive Comparator for Venous Leg Ulcers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 18 years and 80 years of age inclusive, as of the date of screening
- An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at the Screening Visit)
- Index Ulcer is located on the leg, below the knee
- The Index Ulcer is a Venous Leg Ulcer (VLU) greater than 10 cm2, inclusive, at the Screening Visit
- The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit
Key exclusion criteria (22 listed)
- Index Ulcer is of non-venous pathophysiology
- Gangrene is present on any part of the affected limb
- Patient is currently receiving dialysis or planning to go on dialysis
- Patient has a glycated hemoglobin A1c (HbA1c) level of >12%
- Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruSkin | Other | TruSkin® |
| Wound Cover | Other | Wound Cover |
Primary outcome
Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks
Time frame: 8 weeks
6 secondary outcomes
Proportion of patients that achieve complete closure of the index wound by 12 weeks
Time frame: 12 weeks
Proportion of patients that achieve a 50% or greater reduction in wound size by 4 weeks
Time frame: 4 weeks
Time to initial wound closure
Time frame: Up to 84 days
Number of product applications
Time frame: Up to 84 days
Number of AEs
Time frame: Up to 84 days
Number of patients with worsening of index wound defined by ≥ 50% increase in wound size
Time frame: Up to 84 days
Results and safety
The study was stopped early (reason given: Osiris decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TruSkin and Wound Cover in people with Chronic Venous Leg Ulcers, run by Osiris Therapeutics at 7 sites 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 9 inclusion and 22 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 stopped early (reason given: Osiris decision). Results are not available in the source record.
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 patients that achieve a 50% or greater reduction in wound size by 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2017.