WoundsNCT01113307
The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
An observational study of Wounds, run by Macrocure Ltd. at 7 sites in Israel.
Trial summary
The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wounds
- What is being tested?
- Activated allogeneic white blood cells
- How many people
- 131 participants
- Where
- 7 sitesIsrael
- Study dates
- May 2010to Sep 2011
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcers.
Who may be able to join
- Patients between 18 and 90 years of age with one ulcer that has not shown signs of normal healing (according to physician experienced in wound therapy) for more than 3 weeks
- The patient suffers from diabetic ulcer, decubitus ulcer, venous insufficiency ulcer and post operative wound.
- In patients with suspected malnutrition albumin > 2.5 g/dL in blood tests performed within the last three weeks.
- Patients with adequate blood perfusion: palpated distal pulses TP or DP or if not palpable, arterial pressures during rest ABI > 0.6.
- Patients without edema over +2 (patient's edema must be controlled by medical and/or bandaging or lympha press).
- Use of elastic bandaging in wounds due to venous insufficiency (when there is no involvement of an arterial problem).
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- Wound condition does not immediately jeopardize the extremity.
- The patient's life is not at risk (for any reason).
- The Patient has a life expectancy of at least one year.
- Women of childbearing potential must be willing to use reliable methods of birth control.
- Willing and able to sign an informed consent form and attend the follow up according to the treating staff instructions until complete wound closure.
- Inclusion criteria in the 'treatment blinding guessing test':
- A patient suffering from diabetes and a chronic ulcer in the lower extremity (ankle and below) and is CureXcell™ -naive.
- Signing an appendix to the consent form for the 'treatment blinding guessing test'.
Who cannot join
- More than one wound;
- Inadequately treated recurrent pressure components in the wound. If required, ulcer will be treated with preliminary treatment for local pressure components (shoes and even cast or wheel chair for the treatment period)
- Neoplastic ulcer
- A patient with active malignant disease during the last five years, except for a patient suffering from adequately treated Basal Cell Carcinoma which does not present in the wound area.
- Sepsis
- Confirmed osteomyelitis
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- Patients suffering from significant immunosuppression.
- INR > 3 in patients receiving anticoagulation drugs, in blood tests performed within two weeks prior to the first injection
- A response to previous blood infusions (in case administered)
- Patient receiving unique blood components (radiated, washed etc.)
- Pregnant patient
- Wounds for more than a year
- A fistula/cavity which anatomical shape does not enable a direct injection into the wound
- A patient participating in another clinical trial, or who participated in another clinical trial within the last 30 days.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites
Omer Clalit Clinic
Afula
Sold Clalit Clinic
Beersheba
Hamoshava Diabetic Wound Clinic
Jerusalem
Ramat Eshcol Wound Clinic
Jerusalem
Zvulun Wound Clinic
Kiryat Bialik
Hasharon Medical Center
Petah Tikva
Zamenhoff Wound Clinic
Tel Aviv
About this study
Official title: A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds
The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind, placebo controlled study for the evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer treatment, in diabetic patients with ulcers in the lower extremities.
Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcer will be recruited to the study. Patients that have been recruited for the study will be treated as required for their medical condition. As required, cultures will be taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will be referred to catheterization, revascularization, or amputation as required and the decision to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct treatment to good ulcer care (GUC).
- Conditions
- Wounds
- Being tested
- Activated allogeneic white blood cells
- Keywords
- Chronic ulcers, pressure ulcers, venous ulcers, diabetic foot ulcers, post operative ulcers, hard to heal ulcers
- Medical subject headings
- Wounds and Injuries, Pressure Ulcer, Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated allogeneic white blood cellsBiological
Also called CureXcell
The CUREXCELL™ dosage form consists of an activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed).
| Study group | Role | What they receive |
|---|---|---|
| Hard to heal wounds | Not described Receives: Biological: Activated allogeneic white blood cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete wound closure
Measured: Week 24
Secondary outcomes (3)
Median time to complete wound closure
Measured: End of study
Change in wound area between Baseline and Last Observation
Measured: End of study
Rate of wound infections, cellulitis, and osteomyelitis
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macrocure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ram Avrahami, MD, Principal investigator, Clalit Health ServicesDavid Snir, MD, Principal investigator, Clalit Health ServicesYibgeni Sherman, MD, Principal investigator, Clalit Health ServicesDavid Vigoda, MD, Principal investigator, Clalit Health ServicesDimitri Gimelreich, MD, Principal investigator, Clalit Health ServicesAsher Corcos, MD, Principal investigator, Clalit Health ServicesLaios Kazir, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113307
- Sponsor's protocol ID
- MC-103
- Status last verified
- Jan 2013
- First submitted
- 28 Apr 2010
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds
- ClinicalTrials.gov ID
- NCT01113307
- Acronym / sponsor ID
- MC-103
- Conditions
- Wounds
- Keywords
- Chronic ulcers, pressure ulcers, venous ulcers, diabetic foot ulcers, post operative ulcers, hard to heal ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Macrocure Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Apr 2010 (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 primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind, placebo controlled study for the evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer treatment, in diabetic patients with ulcers in the lower extremities.
Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcer will be recruited to the study. Patients that have been recruited for the study will be treated as required for their medical condition. As required, cultures will be taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will be referred to catheterization, revascularization, or amputation as required and the decision to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct treatment to good ulcer care (GUC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hard to heal wounds | – | Biological: Activated allogeneic white blood cells |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcers.
Key inclusion criteria (14 listed)
- Patients between 18 and 90 years of age with one ulcer that has not shown signs of normal healing (according to physician experienced in wound therapy) for more than 3 weeks
- The patient suffers from diabetic ulcer, decubitus ulcer, venous insufficiency ulcer and post operative wound.
- In patients with suspected malnutrition albumin > 2.5 g/dL in blood tests performed within the last three weeks.
- Patients with adequate blood perfusion: palpated distal pulses TP or DP or if not palpable, arterial pressures during rest ABI > 0.6.
- Patients without edema over +2 (patient's edema must be controlled by medical and/or bandaging or lympha press).
Key exclusion criteria (14 listed)
- More than one wound;
- Inadequately treated recurrent pressure components in the wound. If required, ulcer will be treated with preliminary treatment for local pressure components (shoes and even cast or wheel chair for the treatment period)
- Neoplastic ulcer
- A patient with active malignant disease during the last five years, except for a patient suffering from adequately treated Basal Cell Carcinoma which does not present in the wound area.
- Sepsis
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 |
|---|---|---|
| Activated allogeneic white blood cellsAlso: CureXcellThe CUREXCELL™ dosage form consists of an activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed). | Biological | Hard to heal wounds |
Primary outcome
Proportion of patients with complete wound closure
Time frame: Week 24
3 secondary outcomes
Median time to complete wound closure
Time frame: End of study
Change in wound area between Baseline and Last Observation
Time frame: End of study
Rate of wound infections, cellulitis, and osteomyelitis
Time frame: End of study
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 31 Jan 2013.
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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.
Ram Avrahami, MD principal investigator
Clalit Health Services
David Snir, MD principal investigator
Clalit Health Services
Yibgeni Sherman, MD principal investigator
Clalit Health Services
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by Macrocure Ltd. at 7 sites in Israel.
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 14 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 31 Jan 2013. 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 Israel. 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.
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 wound closure (time frame: Week 24). 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 31 Jan 2013.