Pulsed Radio Frequency Energy Therapy Promotes Healing of Lower Extremity Wounds -- Data from the Regenesis Wound Registry

Objectives

To evaluate the extent and rate of wound healing in chronic lower extremity ulcers in a community-based cohort of patients treated for 3 to 4 weeks with pulsed radio frequency energy (PRFE).

Methods

We retrospectively evaluated data from a patient registry sponsored by Regenesis Biomedical, Inc. which contains 464 wounds of various type from 383 patients treated with PRFE from 2005-2008.  From this registry database, 211 chronic lower extremity wounds in 178 patients were identified and analyzed. The wounds were largely recalcitrant to previous therapy. Eighty were diabetic foot ulcers; 76 were venous leg ulcers; and 55 were pressure ulcers. We evaluated the rate of healing and percent reduction in size of the wound (percent wound area reduction, PWAR) as surrogate markers for complete healing.

Results

The majority of patients were elderly and male with wounds of long duration.  A large proportion of wounds reached >50% reduction in size at 4 weeks (DFU 39%; VLU 41%; PU Stage II 90%; PU Stage III 44%; and PU Stage IV 56%). 

Conclusions

The reduction in wound surface area following 3-4 weeks of PRFE therapy is comparable to that reported for other modalities in published clinical trials.  Unlike phase III randomized controlled trials, the Regenesis Registry did not exclude high risk patients. In the Regenesis Registry, wounds were larger and of longer duration than wounds typically enrolled in RCTs. Additional studies are needed to evaluate the potential of pulsed radio frequency energy therapy as an adjunctive therapy in wound healing.