Chronic Venous Leg UlcersPhase 3NCT02130310

Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

A Phase 3 study testing CureXcell® in people with Chronic Venous Leg Ulcers, run by Macrocure Ltd. at 28 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Venous Leg Ulcers
What is being tested?: CureXcell®
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 252 participants
Where: 28 sitesUnited States
Study dates: May 2014to Jun 2016
Phase: Phase 3
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

Ankle Brachial Pressure Index (ABI) ≥ 0.80
Venous insufficiency confirmed by duplex Doppler ultrasound
Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit

Who cannot join

Target Ulcer has decreased >30% in size from Screening to Baseline
Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit.
Patients who are unable to tolerate multi-layer compression therapy.
Ulcer, which in the opinion of the Investigator is suspicious for cancer.
Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
History of radiation at the Target Ulcer site in previous 12 months prior to Baseline Visit.

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Patients with clinically significant claudication
Current sepsis
Patients with known history of significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Carlsbad, California
Study site
Castro Valley, California
Study site
Chapel Hill, North Carolina
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Emerson, New Jersey
Study site
Fresno, California
Study site
Hialeah, Florida
Study site
Indianapolis, Indiana
Study site
Laguna Hills, California
Study site
Las Vegas, Nevada
Study site
Lewisville, Texas
Study site
Los Angeles, California
Study site
McAllen, Texas
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
New York, New York
Study site
Oak Park, Illinois
Study site
Phoenix, Arizona
Study site
San Francisco, California
Study site
South Miami, Florida
Study site
Summit, New Jersey
Study site
Sylmar, California
Study site
Toms River, New Jersey
Study site
Willoughby, Ohio
Study site
Wyomissing, Pennsylvania

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About this study

Official title: A Phase-3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Ulcer Care Measures in Treating Chronic Venous Leg Ulcers

Conditions: Chronic Venous Leg Ulcers
Being tested: CureXcell®, Placebo injection
Keywords: Chronic ulcers, Venous ulcers
Medical subject headings: Varicose Ulcer

What participants receive

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

CureXcell®Biological
CureXcell® is a cell based therapy obtained from donated whole blood. The blood is collected from healthy young adults, the white blood cells are separated and then activated by hypo-osmotic shock.
Placebo injectionOther
Normal saline injected at each centimeter of ulcer bed

Study groups in NCT02130310
Study group	Role	What they receive
CureXcell®	Experimental	CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first. Receives: Biological: CureXcell®
Placebo injection	Placebo comparator	The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed. Receives: Other: Placebo injection

What is being measured

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

Time to complete closure of Target Ulcer
Time to complete closure of Target Ulcer at any time during the 12-week Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
Measured: up to 16 weeks

Secondary outcomes (3)

Proportion of complete closure of Target Ulcer
Proportion of complete closure of Target Ulcer within the Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
Measured: up to 16 weeks
Percentage change from baseline in Target Ulcer surface area
Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase.
Measured: up to 12 weeks
Proportion of Target Ulcer recurrence
Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.
Measured: up to 24 weeks

Timeline

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

May 2014Jun 2016

First posted5 May 2014 (estimated)
Study startMay 2014
Primary completionMay 2016 (estimated)
Study completionJun 2016 (estimated)

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 252 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02130310
Sponsor's protocol ID: MC-105
Status last verified: Sep 2015
First submitted: 1 May 2014
Last updated: 23 Sep 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Venous Leg Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase-3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Ulcer Care Measures in Treating Chronic Venous Leg Ulcers
ClinicalTrials.gov ID: NCT02130310
Acronym / sponsor ID: MC-105
Conditions: Chronic Venous Leg Ulcers
Keywords: Chronic ulcers, Venous ulcers
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 252 participants (estimated)
Lead sponsor: Macrocure Ltd.Industry (pharma, biotech, devices)
Study start: May 2014
Primary completion: May 2016 (estimated)
Study completion: Jun 2016 (estimated)
First posted: 5 May 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CureXcell®	Experimental	Biological: CureXcell®CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
Placebo injection	Placebo comparator	Other: Placebo injectionThe placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Ankle Brachial Pressure Index (ABI) ≥ 0.80
Venous insufficiency confirmed by duplex Doppler ultrasound
Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit

Key exclusion criteria (9 listed)

Target Ulcer has decreased >30% in size from Screening to Baseline
Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit.
Patients who are unable to tolerate multi-layer compression therapy.
Ulcer, which in the opinion of the Investigator is suspicious for cancer.
Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.

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
CureXcell®CureXcell® is a cell based therapy obtained from donated whole blood. The blood is collected from healthy young adults, the white blood cells are separated and then activated by hypo-osmotic shock.	Biological	CureXcell®
Placebo injectionNormal saline injected at each centimeter of ulcer bed	Other	Placebo injection

Primary outcome

Time to complete closure of Target Ulcer
Time frame: up to 16 weeks
Time to complete closure of Target Ulcer at any time during the 12-week Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.

3 secondary outcomes

Proportion of complete closure of Target Ulcer
Time frame: up to 16 weeks
Percentage change from baseline in Target Ulcer surface area
Time frame: up to 12 weeks
Proportion of Target Ulcer recurrence
Time frame: up to 24 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.

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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.

Robert Kirsner, MD, PhD principal investigator

University of Miami

John Lantis, MD principal investigator

St. Luke's-Roosevelt Hospital Center

Robert Snyder, DPM principal investigator

Barry University Clinical Research

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CureXcell® in people with Chronic Venous Leg Ulcers, run by Macrocure Ltd. at 28 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

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?

Time to complete closure of Target Ulcer (time frame: up to 16 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 NCT02130310.

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 23 Sep 2015.