The dermaPACE® System is an FDA-cleared medical device used for treating chronic wounds, particularly diabetic foot ulcers. It uses a non-invasive technology called Pulsed Acoustic Cellular Expression (PACE®)—a type of shockwave therapy—to stimulate the body’s natural healing processes. The dermaPACE® System received FDA clearance in 2017 for the treatment of diabetic foot ulcers, making it the first shockwave therapy device approved for this specific application. This milestone reflects its clinically supported safety and effectiveness in promoting wound healing in chronic, hard-to-treat cases. The system is manufactured by SANUWAVE Health, Inc., a leader in non-invasive regenerative technologies focused on improving patient outcomes through innovation.
This advanced device plays a pivotal role in shockwave wound care in North Hollywood, California, offering a non-surgical method to support faster healing in patients facing persistent wound challenges. Its application extends to those whose ulcers have not improved through conventional methods, making it a valuable addition to chronic wound management.
HOW IT WORKS
- dermaPACE® delivers low-intensity acoustic pressure waves (shockwaves) to the wound site.
- These waves trigger cellular responses, such as increased blood flow, angiogenesis (new blood vessel growth), and collagen production.
- The process supports tissue regeneration and speeds up wound closure.
KEY BENEFITS
- Non-invasive and painless treatment
- Reduces inflammation and infection risk
- Stimulates natural wound healing
- Safe for long-term or repeated use
- Especially effective for diabetic foot ulcers that have not responded to standard care
CLINICAL DATA
The dermaPACE® System is a cutting-edge wound care device that uses proprietary Pulsed Acoustic Cellular Expression (PACE®) technology, a focused form of extracorporeal shockwave therapy designed to stimulate healing at the cellular level. While shockwave therapy has been safely used for decades in orthopedics and kidney stone treatments, dermaPACE® delivers a precisely tuned energy level that enhances tissue repair—without damaging fragile skin cells or surrounding tissues. This makes it ideal for non-invasive wound healing, especially in delicate or chronic wound areas.
Clinically Proven Results Backed by Research
In a large, double-blind randomized clinical trial involving 336 participants with diabetic foot ulcers, the dermaPACE® System demonstrated significant benefits in healing and wound size reduction—outperforming standard care with an excellent safety profile.
Key outcomes from the study include:- Higher Wound Closure Rates at 24 weeks (38% with dermaPACE vs. 26% with control; p=0.023)
- Faster Time to Full Healing (p=0.0346)
- Greater Wound Size Reduction, starting at 6 weeks (p=0.003) and continuing through 24 weeks (p=0.047)
INDICATIONS
The dermaPACE® System is FDA-cleared in the U.S. for use alongside standard wound care in treating chronic diabetic foot ulcers (DFUs). It provides a safe, non-invasive treatment option to help accelerate healing in patients with hard-to-treat DFUs. Clearance: de novo DEN160037
FREQUENTLY ASKED QUESTIONS
Conditions Can dermaPACE® Therapy Treat?
dermaPACE® is FDA-cleared and clinically proven to help heal Diabetic Foot Ulcers (DFUs) by stimulating tissue regeneration and accelerating recovery.
How Long Does dermaPACE® Therapy Take?
Treatment sessions are quick—just a few minutes each, with only a handful of sessions typically needed to activate healing. Standard wound care continues post-treatment. Possible side effects may include redness, tingling, bruising, numbness, or temporary pain.
Is dermaPACE® Therapy Effective?
Yes. dermaPACE® is a non-invasive, advanced therapy designed to reduce healing time for diabetic foot ulcers. It is the first shockwave therapy device cleared by the FDA for this specific use.
How does dermaPACE® therapy support healing in non-diabetic wounds?
While primarily used for diabetic foot ulcers, dermaPACE® may also aid in healing other chronic wounds by stimulating blood flow and encouraging new tissue growth.
What cellular changes occur during dermaPACE® treatment?
The therapy triggers angiogenesis and collagen production, which contribute to faster wound closure and enhanced tissue repair at the microscopic level.
Who may not be a candidate for dermaPACE® therapy?
Patients with untreated infections, active bleeding, or certain circulatory conditions may require alternative treatment approaches based on clinical evaluation.
How is progress monitored during a course of dermaPACE® sessions?
Clinicians typically assess changes in wound size, tissue appearance, and healing rate over time to determine how well the treatment is working.
Experience Better Wound Healing
Experience faster recovery with our advanced wound care solutions. Our experts at AcuHeal Wound Specialists are ready to help you heal better, sooner. Contact us now for personalized wound care.