The WOCN Society 40th Annual Conference (June 21-25th, 2008)


2418

Cell Proliferation Induction (CPIŽ) Wound Therapy in Venous Stasis Ulcers: A Prospective, Multi-Center Case Series of 26 Ulcers Across Various Sites of Care

Richard A. Isenberg, MD, FAPWCA, Regenesis Biomedical, Inc, Vice President, Clinical & Regulatory Affairs and Medical Director, 1435 N. Hayden Rd, Scottsdale, AZ 85257

Rationale: Venous stasis ulcers of the lower extremity require prolonged and multimodal intervention.  Cell Proliferation Induction (CPI)* therapy, a radio-frequency based wound treatment technology, has been shown in vitro to trigger a cytogenetic response comparable to that of normal wound healing, accelerate the cell cycle, increase cell mitosis in human skin cell lines, and induce the production of multiple endogenous growth factors.   This study investigates the effectiveness of CPI in the healing of Venous Stasis Ulcers in out-patient and long-term care settings.  


 Methods:  This was a prospective, open-label, non-comparative case series at 13 US medical centers.  Sites of care included wound clinics, long term care facilities, skilled nursing facilities, hospitals and nursing homes.  Data collected included subject age, gender, wound type, location, dimensions and wound age.  Subjects were treated with CPI for  3 to 8 weeks.  All subjects received CPI therapy as an adjunct to standard clinical wound care protocols.  

Results:  26 wounds in 22 patients were studied. Of these, 8 were treated for 3 weeks and 18 were treated for 4 weeks.  Wounds were very large, with mean wound surface area of 59.1 cm2. The wounds were chronic, with mean wound age of 19.5 months.  The population was elderly, with mean age 71.9 years. Over the course of the first month of CPI therapy, the percentage of Venous Stasis ulcers which closed was 7.7%; and the percentage which reduced in surface area by >90% was 23.1%.  Fifty four (54) percent of wounds reached 50% closure during the 4-week trial.  Overall, Venous Stasis Ulcers reduced 58.9% in surface area during treatment, with a healing rate of 87.6 mm2/day.  


 Conclusions:  CPI therapy is found to promote the healing of large, chronic Venous Stasis Ulcers in a variety of out-patient clinics and long-term care facilities.

* PROVANT Wound Therapy System (Regenesis Biomedical, Inc., Scottsdale AZ)


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