The Wound Healing Response of Venous Leg Ulcers to Out-Patient Pulsed Radio Frequency Energy Treatment: Analysis of an 85-Wound Registry

Rationale:           Pulsed Radio Frequency Energy (PRFE) therapy has been used for treatment of chronic, non-healing wounds since 2004.  The PRFE device emits a fixed dose of non-ionizing, non-thermal radio frequency energy, transmitted via an applicator pad placed adjacent to the patient’s dressed wound. Treatment is self-administered in the home or facility setting. Recent case reports have shown a beneficial effect in the adjunctive treatment of diabetic foot ulcers and pressure ulcers.  This case series examines wound healing outcomes in a series of 85 venous leg ulcers.

Methods:            67 consecutive patients receiving treatment with PRFE for Venous Leg Ulcers were registered into a wound database between 2005 and 2008. Cases originated from 39 geographically distributed US out-patient centers.  Most wounds had been unresponsive to previous therapies.   Data collected included subject age, gender, wound type and location, age of wound and dimensions.  PRFE therapy was prescribed as an adjunct to standard wound care protocols and assessed at 4 weeks.

Results:                85 wounds were included in the analysis.  Patients were elderly with median age 68.8 years (Mean 69, SD 13.4, Min 32, Max 95), and had complex co-morbidities.  Wounds were chronic with median wound age 12.0 months (mean 44.7, SD 98.4, Min 0.3, Max 504), and large (median surface area 17.5 cm², mean 51.6, SD 87.9, Min 0.9, max 604.8).  In the first month of therapy, wound surface area decreased by a median of 37.5%.  Twenty Seven percent (27%) of wounds reached 50% closure;  3.5% healed completely.  The wound healing rate (DSA/days) was 19 mm²/day, almost twice the rate among venous leg ulcers treated with standard care (11mm²/day) in the control group of randomized trials.

Conclusions:      Venous leg ulcers treated with Pulsed Radio Frequency Energy are found to have a substantial reduction in size in the first 4 weeks, and to heal at a rate almost twice that of wounds treated with standard, basic wound care.