The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
NCT ID: NCT01113307
Last Updated: 2013-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
131 participants
OBSERVATIONAL
2010-05-31
2011-09-30
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hard to heal wounds
Activated allogeneic white blood cells
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).
Interventions
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Activated allogeneic white blood cells
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The patient suffers from diabetic ulcer, decubitus ulcer, venous insufficiency ulcer and post operative wound.
3. In patients with suspected malnutrition albumin \> 2.5 g/dL in blood tests performed within the last three weeks.
4. Patients with adequate blood perfusion: palpated distal pulses TP or DP or if not palpable, arterial pressures during rest ABI \> 0.6.
5. Patients without edema over +2 (patient's edema must be controlled by medical and/or bandaging or lympha press).
6. Use of elastic bandaging in wounds due to venous insufficiency (when there is no involvement of an arterial problem).
7. Wound condition does not immediately jeopardize the extremity.
8. The patient's life is not at risk (for any reason).
9. The Patient has a life expectancy of at least one year.
10. Women of childbearing potential must be willing to use reliable methods of birth control.
11. Willing and able to sign an informed consent form and attend the follow up according to the treating staff instructions until complete wound closure.
1. A patient suffering from diabetes and a chronic ulcer in the lower extremity (ankle and below) and is CureXcell™ -naive.
2. Signing an appendix to the consent form for the 'treatment blinding guessing test'.
Exclusion Criteria
2. 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)
3. Neoplastic ulcer
4. 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.
5. Sepsis
6. Confirmed osteomyelitis
7. Patients suffering from significant immunosuppression.
8. INR \> 3 in patients receiving anticoagulation drugs, in blood tests performed within two weeks prior to the first injection
9. A response to previous blood infusions (in case administered)
10. Patient receiving unique blood components (radiated, washed etc.)
11. Pregnant patient
12. Wounds for more than a year
13. A fistula/cavity which anatomical shape does not enable a direct injection into the wound
14. A patient participating in another clinical trial, or who participated in another clinical trial within the last 30 days.
18 Years
90 Years
ALL
No
Sponsors
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Macrocure Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ram Avrahami, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
David Snir, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Yibgeni Sherman, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
David Vigoda, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Dimitri Gimelreich, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Asher Corcos, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Laios Kazir, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Locations
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Omer Clalit Clinic
Afula, , Israel
Sold Clalit Clinic
Beersheba, , Israel
Hamoshava Diabetic Wound Clinic
Jerusalem, , Israel
Ramat Eshcol Wound Clinic
Jerusalem, , Israel
Zvulun Wound Clinic
Kiryat Bialik, , Israel
Hasharon Medical Center
Petah Tikva, , Israel
Zamenhoff Wound Clinic
Tel Aviv, , Israel
Countries
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Other Identifiers
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MC-103
Identifier Type: -
Identifier Source: org_study_id