Lower Extremity Chronic Ulcers in DiabeticsPhase 3NCT01421966
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
A Phase 3 study testing CureXcell® in people with Lower Extremity Chronic Ulcers in Diabetics, run by Macrocure Ltd. at 37 sites in 3 countries.
Trial summary
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Chronic Ulcers in Diabetics
- 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
- 285 participants
- Where
- 37 sitesin 3 countries
- Study dates
- Aug 2011to Oct 2015
- 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
- Males or females at least 18 years of age with diabetes type 1 or type 2;
- Patients with HbA1c ≤ 12%;
- Patients with at least one lower extremity (on or below the malleolus (ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), which has been unresponsive to any treatment for at least 4 weeks;
- Ulcers with an area between ≥ 1 cm2 and ≤ 20 cm2 (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue to the extent possible);
- Ankle Brachial Index ≥ 0.65;
Who cannot join
- Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;
- Patients with ulcers primarily caused by venous insufficiency;
- Patients whose target ulcer has decreased > 25% in size from screening to baseline;
- Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
- Significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV;
- Current clinical osteomyelitis;
- Acute Charcot foot;
- Current sepsis;
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
United States31 sites
Study site
Aiken, South Carolina
Study site
Arlington Heights, Illinois
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Evans, Georgia
Study site
Fresno, California
Study site
Glendale, Arizona
Study site
Greenville, South Carolina
Study site
Gulf Breeze, Florida
Study site
Hialeah, Florida
Study site
Indianapolis, Indiana
Study site
Kansas City, Missouri
Study site
Lewisville, Texas
Study site
Lima, Ohio
Study site
McAllen, Texas
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
Mineola, New York
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Oak Park, Illinois
Study site
Phoenix, Arizona
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
South Miami, Florida
Study site
Sylmar, California
Study site
Toms River, New Jersey
Study site
Tucson, Arizona
Study site
Wichita, Kansas
Israel4 sites
Study site
Haifa
Study site
Holon
Study site
Jerusalem
Study site
Tel Aviv
About this study
Official title: A Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 280 patients will be randomized to receive either CureXcell® or sham.
Read the detailed description
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United States and in general worldwide. Foot ulceration is a serious complication of diabetes mellitus associated with increased risk of infection, gangrene and amputation. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. Despite existing ulcer therapies and technologies, there continues to be a great necessity for new wound healing technologies that will further improve healing rates for these chronic ulcers that remain a major source of morbidity, concern, and cost. This Phase 3 multinational, multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell® in treating lower extremity chronic ulcers in adults with Diabetes Mellitus.
CureXcell® is a cell based therapy obtained from donated whole blood. The blood are collected from healthy, young adult (age 18-40), the cells separated and then activated by hypo-osmotic shock.
A total of 280 patients, in approximately 35 sites in the US, Canada and Israel, will be randomized to receive either CureXcell® or control.
The primary objective of the study is to evaluate the clinical benefit of CureXcell® (study biologic) compared to control, as adjunct to Good Ulcer Care. Additional objectives are to demonstrate safety, tolerability and durability of CureXcell® compared to control.
The study has two phases: a core double-blind phase and a follow up phase.
- Being tested
- CureXcell®, Sham injection
- Keywords
- chronic ulcers, diabetic foot ulcers
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CureXcell®Biological
CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
Sham injectionBiological
The sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed
| Study group | Role | What they receive |
|---|---|---|
| CureXcell® | Experimental | Not described Receives: Biological: CureXcell® |
| Sham injection | Sham comparator | Not described Receives: Biological: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up.
Measured: up to 20 weeks
Secondary outcomes (3)
Time to complete closure of the Target Ulcer during the core double blind treatment phase with sustained complete closure for 4 additional weeks of follow-up.
Measured: up to 20 weeks
Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period.
Measured: 16 weeks
Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit.
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Chronic Ulcers in DiabeticsStudies 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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macrocure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research, ICON plc, ARANZ Medical
- Responsible party
- Sponsor
- Investigators
- Vickie Driver, MS, DPM, FACFAS, Principal investigator, VA New England Health Care Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421966
- Sponsor's protocol ID
- MC-102
- Status last verified
- Dec 2015
- First submitted
- 21 Aug 2011
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01421966
- Acronym / sponsor ID
- MC-102
- Keywords
- chronic ulcers, diabetic foot ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Macrocure Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research, ICON plc, ARANZ Medical
- Study start
- Aug 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Aug 2011 (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.
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 280 patients will be randomized to receive either CureXcell® or sham.
Detailed description
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United States and in general worldwide. Foot ulceration is a serious complication of diabetes mellitus associated with increased risk of infection, gangrene and amputation. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. Despite existing ulcer therapies and technologies, there continues to be a great necessity for new wound healing technologies that will further improve healing rates for these chronic ulcers that remain a major source of morbidity, concern, and cost. This Phase 3 multinational, multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell® in treating lower extremity chronic ulcers in adults with Diabetes Mellitus.
CureXcell® is a cell based therapy obtained from donated whole blood. The blood are collected from healthy, young adult (age 18-40), the cells separated and then activated by hypo-osmotic shock.
A total of 280 patients, in approximately 35 sites in the US, Canada and Israel, will be randomized to receive either CureXcell® or control.
The primary objective of the study is to evaluate the clinical benefit of CureXcell® (study biologic) compared to control, as adjunct to Good Ulcer Care. Additional objectives are to demonstrate safety, tolerability and durability of CureXcell® compared to control.
The study has two phases: a core double-blind phase and a follow up phase.
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® |
| Sham injection | Sham comparator | Biological: Sham injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females at least 18 years of age with diabetes type 1 or type 2;
- Patients with HbA1c ≤ 12%;
- Patients with at least one lower extremity (on or below the malleolus (ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), which has been unresponsive to any treatment for at least 4 weeks;
- Ulcers with an area between ≥ 1 cm2 and ≤ 20 cm2 (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue to the extent possible);
- Ankle Brachial Index ≥ 0.65;
Key exclusion criteria (8 listed)
- Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;
- Patients with ulcers primarily caused by venous insufficiency;
- Patients whose target ulcer has decreased > 25% in size from screening to baseline;
- Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
- Significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV;
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® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first. | Biological | CureXcell® |
| Sham injectionThe sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed | Biological | Sham injection |
Primary outcome
Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up.
Time frame: up to 20 weeks
3 secondary outcomes
Time to complete closure of the Target Ulcer during the core double blind treatment phase with sustained complete closure for 4 additional weeks of follow-up.
Time frame: up to 20 weeks
Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period.
Time frame: 16 weeks
Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit.
Time frame: up to 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
Vickie Driver, MS, DPM, FACFAS principal investigator
VA New England Health Care Division
37 sites in 3 countries: 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 Lower Extremity Chronic Ulcers in Diabetics, run by Macrocure Ltd. at 37 sites in 3 countries.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Israel, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up. (time frame: up to 20 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 7 Dec 2015.