The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Macrocure Ltd.
ClinicalTrials.gov Identifier:
NCT01113307
First received: April 28, 2010
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Wounds
Biological: Activated allogeneic white blood cells

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Macrocure Ltd.:

Primary Outcome Measures:
  • Proportion of patients with complete wound closure [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median time to complete wound closure [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Change in wound area between Baseline and Last Observation [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Rate of wound infections, cellulitis, and osteomyelitis [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Enrollment: 131
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hard to heal wounds Biological: 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 Name: CureXcell

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcers.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113307

Locations
Israel
Omer Clalit Clinic
Afula, Israel
Sold Clalit Clinic
Be'er-Sheva, Israel
Ramat Eshcol Wound Clinic
Jerusalem, Israel
Hamoshava Diabetic Wound Clinic
Jerusalem, Israel
Zvulun Wound Clinic
Kiryat Bialik, Israel
Hasharon Medical Center
Petach Tikva, Israel
Zamenhoff Wound Clinic
Tel Aviv, Israel
Sponsors and Collaborators
Macrocure Ltd.
Investigators
Principal Investigator: Ram Avrahami, MD Clalit Health Services
Principal Investigator: David Snir, MD Clalit Health Services
Principal Investigator: Yibgeni Sherman, MD Clalit Health Services
Principal Investigator: David Vigoda, MD Clalit Health Services
Principal Investigator: Dimitri Gimelreich, MD Clalit Health Services
Principal Investigator: Asher Corcos, MD Clalit Health Services
Principal Investigator: Laios Kazir, MD Clalit Health Services
  More Information

No publications provided

Responsible Party: Macrocure Ltd.
ClinicalTrials.gov Identifier: NCT01113307     History of Changes
Other Study ID Numbers: MC-103
Study First Received: April 28, 2010
Last Updated: January 30, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Macrocure Ltd.:
Chronic ulcers
pressure ulcers
venous ulcers
diabetic foot ulcers
post operative ulcers
hard to heal ulcers

ClinicalTrials.gov processed this record on September 18, 2014