Abstract: Pulsed Radio Frequency Energy in the Treatment of Diabetic Foot Ulcers: A Series of 78 Cases (WOCN Society 41st Annual Conference (June 6- June 10, 2009))

3433 Pulsed Radio Frequency Energy in the Treatment of Diabetic Foot Ulcers: A Series of 78 Cases

Richard A. Isenberg, MD, FAPWCA , Regenesis Biomedical, Inc, Vice President, Clinical & Regulatory Affairs and Medical Director, Scottsdale, AZ
Title:                     PULSED RADIO FREQUENCY ENERGY IN THE TREATMENT OF DIABETIC FOOT ULCERS:

A Registry of 78 Wounds

Purpose:              Pulsed radio frequency energy (PRFE) induces proliferation of cultured human fibroblasts and keratinocytes in a complex biophysical interaction involving the MAP Kinase p44/42 pathway, and incites the expression of hundreds of genes associated with wound healing.  Recent case reports have shown a beneficial effect in the adjunctive treatment of diabetic foot ulcers.  This case series examines wound healing outcomes in a series of 79 diabetic foot ulcers.

Methods:            This is a retrospective review of consecutive patient records at 30 geographically distributed US out-patient centers.    Subjects each had a diabetic foot ulcer treated with PRFE during 2005-2008. Most subjects had recalcitrant wounds which had been unresponsive to previous advanced wound therapies.  Data collected included subject age, gender, wound type and location, age of wound and dimensions.  PRFE therapy was prescribed for home use as an adjunct to standard wound care protocols. Response to treatment was assessed at 4 weeks.

Results:                78 wounds were included in the analysis.  Patients were elderly with median age 61 (Mean 63, SD 8.9, Min 46, Max 84), and had complex co-morbidities.  Wounds were chronic with median wound age 12.5 months (Mean 22.2 months, SD 21.5, Min 1.5 months, Max 108 months), and large (Median surface area 3.7 cm2, Mean 7.3 cm2, SD 9.9, Min 0.01, Max 50.0 cm2).  In the first month of therapy, wound surface area decreased by a median of 36.7%.  Thirty Two percent (32%) of wounds reached 50% closure with 4 weeks of therapy and 5.8% healed completely.  The wound healing rate (DSA/days) was 3.6 mm2/day, quadruple the rate among diabetic neuropathic ulcers treated with standard care (0.83 mm2/day, Zimny 2002).

Conclusions:      In this series of 78 chronic diabetic ulcers, PRFE is found to promote and accelerate wound healing.

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