Stimulate tissue repair and speed recovery with acoustic shockwaves

The dermaPACE® System is an FDA-cleared device designed to treat chronic wounds, with a strong focus on diabetic foot ulcers. This advanced therapy uses Pulsed Acoustic Cellular Expression (PACE®) technology—a form of acoustic shockwave therapy—to activate the body’s natural healing mechanisms.

Cleared by the FDA in 2017, dermaPACE® became the first shockwave therapy device approved for diabetic foot ulcers, highlighting its proven safety and effectiveness in chronic wound management. Manufactured by SANUWAVE Health, Inc., it represents a breakthrough in non-invasive regenerative care.

At Profound Wound Specialists, a leading provider of clinical wound care in Los Angeles, California, we use dermaPACE® to help patients with hard-to-heal wounds who have not improved with standard treatments, offering a non-surgical solution that accelerates recovery.

How It Works

  • dermaPACE® delivers low-intensity acoustic pressure waves directly to the wound site.
  • These waves stimulate blood flow, angiogenesis (new blood vessel growth), and collagen production.
  • The process encourages tissue regeneration, reduces healing delays, and supports wound closure.

Key Benefits

  • Non-invasive and pain-free therapy
  • Reduces inflammation and lowers infection risk
  • Stimulates natural healing at the cellular level
  • Safe for repeated or long-term use
  • Clinically effective for diabetic foot ulcers unresponsive to conventional care

Clinical Data

The dermaPACE® System uses advanced PACE® shockwave technology, adapted from decades of safe use in orthopedics and kidney stone treatments. Unlike high-energy devices, dermaPACE® is precisely calibrated to stimulate cellular repair without damaging fragile tissues, making it ideal for sensitive or chronic wounds.

Proven Results From Clinical Trials

In a double-blind randomized clinical trial of 336 patients with diabetic foot ulcers, dermaPACE® significantly outperformed standard care:

  • Higher wound closure rates at 24 weeks (38% with dermaPACE® vs. 26% with control; p=0.023)
  • Faster healing times (p=0.0346)
  • Greater wound size reduction starting at 6 weeks and sustained through 24 weeks (p=0.003–0.047)

These outcomes confirm dermaPACE® as an effective, safe, and non-invasive therapy for diabetic foot ulcers.

Indications

The dermaPACE® System is FDA-cleared for use alongside standard wound care in the treatment of chronic diabetic foot ulcers (DFUs). It provides a safe, non-surgical therapy option for patients with difficult-to-treat wounds. Clearance: de novo DEN160037.

Frequently Asked Questions (FAQs)

What types of wounds can dermaPACE® therapy help treat?
dermaPACE® is FDA-cleared for diabetic foot ulcers and has shown clinical effectiveness in stimulating wound healing. It may also benefit other chronic wounds by enhancing blood flow and tissue regeneration.
How long does a dermaPACE® session take?
Treatment sessions typically last only a few minutes. In most cases, just a handful of sessions are needed to activate the healing response. Patients continue with standard wound care after treatment. Possible side effects include mild redness, tingling, numbness, bruising, or temporary discomfort.
Is dermaPACE® therapy effective for wound healing?
Yes. dermaPACE® is the first FDA-cleared shockwave therapy device proven to reduce healing time for diabetic foot ulcers. Clinical trials confirm its safety and superior healing results compared to conventional care.
Can dermaPACE® therapy be used for wounds other than diabetic ulcers?
While its primary indication is for diabetic foot ulcers, dermaPACE® may support healing in other chronic wounds by increasing blood circulation, stimulating angiogenesis, and encouraging tissue repair.
What happens at the cellular level during dermaPACE® treatment?
The therapy triggers angiogenesis (new blood vessel growth) and collagen production, both of which promote 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 vascular conditions may require alternative wound care options. A clinical evaluation determines suitability for treatment.
How do clinicians monitor progress during dermaPACE® therapy?
Healing progress is tracked through wound measurements, tissue appearance, and closure rate over time. Regular assessments help providers determine effectiveness and make necessary adjustments.

Begin Your Healing Journey

Don’t ignore wounds that are slow to heal or cause ongoing pain. At Profound Wound Specialists, we are committed to restoring health, comfort, and mobility through advanced wound care. Contact us today to schedule a consultation and take the first step toward recovery.