Changes In Wound Closure Rate Over Time In a Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study of Shockwave Technology for the Treatment of Non-Healing Diabetic Foot Ulcers

Purpose

Pulsed acoustic shockwaves cause expression of multiple angiogenic growth factors which promote wound healing.¹ An FDA Investigational Device Exemption (IDE) study was performed to the evaluate safety/efficacy of a pulsed acoustic cellular expression (PACE) device in healing diabetic foot ulcers (DFU) unresponsive to conservative therapy. This paper examines healing rates with PACE to identify an endpoint to the clinical response to the treatment.

Methods

This prospective, randomized, double-blinded, sham-controlled, multicenter, parallel group study enrolled patients with Texas Diabetic Wound Classification System Grade 1 or 2 DFU with ≥30 day persistence despite standard of care. Four active or sham shockwave treatments were delivered over 2 weeks (dermaPACE^®, SANUWAVE, Alpharetta, GA). Endpoints included rate of wound closure, time to closure, area reduction, safety and pain.

Experience

206 patients were randomized into active(n=107) or sham(n=99) treatment groups and followed 12 weeks for efficacy and 24 weeks for safety/recurrence.

Summary of Results

90-100% wound closure by 12 weeks was obtained in 48% of PACE versus 31% of sham patients (p=0.0161).  Mean reduction in target ulcer area at 12 weeks for PACE patients was 54%, versus 7% for sham (p=0.004). Mean ulcer area in the sham group initially decreased 20% early in the evaluation period, but by 6 weeks showed a progressive increase in size through week 12. Conversely, mean ulcer area for PACE patients decreased throughout the 12-week evaluation period, steeply during active treatment, then at a slower pace, then at nearly plateau at 9-12 weeks (Figure 1). 

Conclusions

Mean ulcer size for PACE treated patients decreased significantly compared to sham control between 6-12 weeks. The rate of wound area reduction after week 10 indicating diminished PACE treatment effects.  Future investigation should evaluate whether a second course of PACE treatments at that time point can initiate a new cycle of rapid healing response.

1.       Krokowicz L, Cwykiel J, Klimczak A, Mielniczuk M, Siemionow M: Pulsed Acoustic Cellular Treatment Induces Expression of Proangiogenic Factors and Chemokines in Muscle Flaps.  J Trauma. 2010 Dec; 69:1448-56