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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT01113307 |
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Date of registration:
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28/04/2010 |
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Primary sponsor: |
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Public title:
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The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
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Scientific title:
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A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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131 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01113307 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Israel
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Contacts
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Name:
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Asher Corcos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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David Snir, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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David Vigoda, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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Dimitri Gimelreich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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Laios Kazir, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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Ram Avrahami, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Name:
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Yibgeni Sherman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clalit Health Services |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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
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.
Inclusion criteria in the 'treatment blinding guessing test':
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:
1. More than one wound;
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.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wounds
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Intervention(s)
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Biological: Activated allogeneic white blood cells
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Primary Outcome(s)
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Proportion of patients with complete wound closure
[Time Frame: Week 24]
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Secondary Outcome(s)
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Change in wound area between Baseline and Last Observation
[Time Frame: End of study]
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Median time to complete wound closure
[Time Frame: End of study]
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Rate of wound infections, cellulitis, and osteomyelitis
[Time Frame: End of study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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