Extracorporeal shock wave therapy (ESWT) has emerged as a promising modality for wound healing and tissue regeneration. Among the available devices, Dermapace by SANUWAVE is an FDA-cleared ESWT system specifically indicated for chronic diabetic foot ulcers (DFUs). It delivers focused shockwaves to stimulate tissue repair. Clinical studies suggest that Dermapace can improve wound closure rates when used alongside standard care, making it a viable option for managing chronic DFUs.
What Is the Dermapace Sanuwave?
The Dermapace System, developed by SANUWAVE Health, Inc., is an ESWT-engineered device for diabetic foot ulcers, providing a non-invasive, adjunctive treatment for chronic wounds.
Dermapace utilizes high-energy, focused extracorporeal shockwaves to activate the body’s normal regenerative processes and facilitate healing at the cellular level. It employs pulsed acoustic cellular expression (PACE®) technology, which is tuned to promote tissue repair without causing damage to cellular structures in the wound bed, periwound, or deeper tissues. The system is indicated for the treatment of chronic DFUs in conjunction with standard care.
Mechanism of Action: How Does Dermapace Work?
These shockwaves penetrate deep into the tissue, stimulating biological responses at the cellular level, including increased perfusion, growth factor upregulation, inflammatory modulation, and angiogenesis. Collectively, these effects activate the body’s natural regenerative processes, expedite healing at the cellular level, and promote robust and durable wound closure.
Efficacy of Dermapace for Diabetic Foot Ulcers: Clinical Evidence
A randomized, double-blind, sham-controlled phase III clinical trial by Snyder et al. (2018) evaluated Dermapace’s effectiveness in treating chronic DFUs. The study included 336 patients, with results showing that at 20 weeks, 35.5% of ulcers in the active therapy group achieved full closure compared to 24.4% in the sham group (p=0.027). By 24 weeks, 37.8% of patients treated with focused ESWT experienced complete wound healing versus 26.2% in the sham group (p=0.023) (Snyder et al., 2018).
A secondary analysis by Galiano et al. (2019) further supported these results, showing that patients receiving Dermapace had a 48.6% reduction in wound area compared to 10.7% in the sham group (p=0.015) and a significantly shorter time to closure (84 vs. 112 days; p=0.0346). However, limitations were noted, including variability in patient response, with some wounds not achieving full closure even after 24 weeks. Additionally, treatment required multiple sessions over several weeks, which may pose logistical challenges for both patients and providers. While no significant increase in pain or infection was observed, the therapy’s effectiveness depends on patient adherence and proper wound care management (Galiano et al., 2019).
Beyond Dermapace: The Next Generation of Shockwave Therapy
As shockwave therapy continues to evolve, advancements in technology have led to improved treatment efficacy and expanded clinical applications. SoftWave Technology, particularly their SoftWave Gold Li-Series device, represents the next generation of shockwave technology. This patented technology enables wider energy dispersion, making it particularly beneficial for treating large or complex tissue regions without excessive mechanical stress.
SoftWave Therapy: A Broad-Focused Approach to Healing
SoftWave Therapy differs from traditional focused ESWT devices like Dermapace by employing a patented parabolic reflector applicator, which generates both primary and secondary acoustic waves. This design allows for uniform energy distribution across a larger area, reducing localized tissue stress while maintaining the biological effects necessary for healing.
Mechanism of Action
- Broad Energy Distribution – Unlike focused ESWT, which directs high-energy pulses to a single focal point, SoftWave Therapy disperses shockwaves over a wider treatment zone, leading to a more comprehensive biological response.
- Stimulation of Cellular Regeneration – The mechanical stimulation of SoftWave Therapy activates stem cells, enhances growth factor release, and promotes neovascularization, improving tissue repair and regeneration.
- Modulation of Inflammatory Pathways – SoftWave Therapy reduces chronic inflammation by downregulating pro-inflammatory cytokines while simultaneously promoting the release of anti-inflammatory mediators.
- Enhanced Blood Flow and Angiogenesis – The therapy stimulates vascular endothelial growth factor (VEGF) production, which plays a crucial role in angiogenesis and microcirculation improvements in ischemic or damaged tissues.
Unlike high-intensity focused shockwaves, which may require anesthesia for patient comfort, SoftWave Therapy delivers energy more gently without compromising efficacy, making treatments more tolerable without requiring local numbing agents.
Conditions Treated by SoftWave Therapy
SoftWave Therapy extends beyond chronic diabetic foot ulcers to address a wide range of clinical conditions, including:
- Orthopedic and Musculoskeletal Disorders – Tendinopathies, stress fractures, ligament injuries, and joint degeneration.
- Chronic Pain Management – Myofascial pain, plantar fasciitis, osteoarthritis, and nerve-related conditions.
- Wound Healing and Tissue Regeneration – Chronic ulcers, burns, and post-surgical tissue repair.
- Urological and Sexual Health Applications – Erectile dysfunction (ED), Peyronie’s disease, and pelvic pain syndromes (Health Canada Licensed, not FDA-cleared for these indications).
- Neurological and Regenerative Applications – Peripheral nerve injuries, stroke recovery, and post-trauma rehabilitation.
The versatility of SoftWave Therapy makes it an attractive alternative for clinics seeking a multi-purpose shockwave system capable of treating a wide range of patient populations.
How SoftWave Compares to Dermapace
While both SoftWave Therapy and Dermapace utilize ESWT, their energy delivery and treatment applications differ significantly.
| Feature | SoftWave Therapy | Dermapace (SANUWAVE) |
| Shockwave Type | Broad-Focused (Unfocused ESWT) | Focused ESWT |
| Energy Distribution | Covers a larger treatment area, leading to wider biological activation | Concentrates energy into a single focal point |
| Primary Mechanisms | Stimulates angiogenesis, activates cellular repair, and modulates inflammation | Accelerates localized wound healing through microcirculation improvements |
| Primary Indications | Musculoskeletal, orthopedic, chronic pain, wound healing | Diabetic foot ulcers and chronic wounds |
| Treatment Comfort | More tolerable due to lower peak energy concentration | May require higher energy levels, increasing discomfort in some cases |
| Regulatory Approvals | FDA-cleared, Health Canada Licensed | FDA-cleared for DFU treatment |
Take Your Practice to the Next Level with SoftWave Therapy
The continuous advancement of shockwave technology has led to improved patient outcomes, more efficient treatment protocols, and greater versatility in clinical use. SoftWave Therapy provides:
- Optimized broad-focused energy delivery for enhanced tissue healing.
- Patented parabolic reflector technology that maximizes shockwave penetration.
- FDA clearance for orthopedic, musculoskeletal, and wound healing applications.
- Shorter treatment sessions with improved patient tolerability.
For clinics looking to expand their therapeutic offerings, SoftWave Therapy represents a cutting-edge, non-invasive solution that delivers clinically validated results across multiple medical disciplines.
