A Post-marketing Observational Study of Cell Therapy for Chronic Wounds

Launched by MACROCURE LTD. · Dec 23, 2009

Keywords

ClinConnect Summary

Chronic wounds can be categorized into two main groups: (a) chronic ulcers, such as diabetic foot ulcers, venous leg ulcers and pressure (decubitus) ulcers (b) post-operative or traumatic, difficult-to-heal wounds, some of which may be infected such as sternal wound infections following cardiac surgery or wounds following abdominal or orthopedic surgery. Age, peripheral vascular disease, infection, diabetes mellitus, auto-immune dis., obesity, cardiac disease, cardiac failure, malnutrition, immunological deficiencies, steroid treatment, bed confinement and prolonged operation time are among...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with chronic and/or refractory wounds that have been referred by their physician for CUREXCELLTM treatment
• • Signed consent form
• • INCLUSION CRITERIA FOR THE BLINDING GUESSING TEST
• • Patients with chronic lower extremity ulcers (on malleoli and below) and diabetes mellitus
• • Signed the blinding guessing test section of the consent form
• • Were not treated in the past by CureXcell
• Exclusion Criteria:
• • Patients with known or suspected present malignancy (except for successfully treated basal cell carcinoma) within the past 3 years.
• • Patients with gangrene
• • Patients for whom amputation or a complete resection of the infection site is planned component of treatment
• • Patients simultaneously participating in any interventional clinical trial
• • Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements