Methods:  This was a prospective, open-label, non-comparative case series at 10 geographically distributed US out-patient wound care clinics.    Data collected included subject age, gender, wound type and location, age of wound and dimensions.  All subjects were treated with CPI therapy for between 3 and 4 weeks. CPI therapy was prescribed by physicians for supervised use in the home as an adjunct to standard clinic wound care protocols.  Patients were trained in the instructions for use and monitored for compliance by study personnel.
Results:  25 wounds in 21 patients were selected for study. Among these, 5 wounds were treated for 3 weeks and 20 were treated for 4 weeks. The average patient age was 61.2 years.  Wounds were primarily foot ulcers, with mean initial wound surface area of 4.4 cm².   Wounds were chronic, with an average age of 23.5 months.  Over the course of the first month of CPI therapy, the percentage of diabetic wounds which closed was 4%, and the percentage which reduced in area by >50% was 64%.  Overall, Diabetic ulcers were reduced 23.8% in surface area during the first month of treatment, with a healing rate of 7.2 mm²/day.   No adverse events were noted.

Conclusions:  CPI therapy promotes the healing of Diabetic Ulcers when used at home under out-patient physician supervision.  Considerable progress to wound closure was accomplished in 4 weeks of CPI therapy.

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