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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 CureXcellâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hard to heal wounds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated allogeneic white blood cells | Biological | The CUREXCELLâ„¢ 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with complete wound closure | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to complete wound closure | End of study | |
| Change in wound area between Baseline and Last Observation | End of study | |
| Rate of wound infections, cellulitis, and osteomyelitis |
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Inclusion Criteria:
Inclusion criteria in the 'treatment blinding guessing test':
Exclusion Criteria:
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Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcers.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omer Clalit Clinic | Afula | Israel | ||||
| Sold Clalit Clinic |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D003668 | Pressure Ulcer |
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
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|
| End of study |
| 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |