PACE® Therapy Offers Patients the Best Chance of Healing: Use Energy First

Diabetic patients that develop chronic wounds have comorbidities that can make healing difficult. They deserve the greatest chance for accelerated wound healing. Our leading, end-to-end, advanced wound care solution, SANUWAVE’s dermaPACE System activates the body’s normal regenerative processes, expedites curing at the cellular level and ultimately produces a robust and durable wound healing.

What PACE Extracorporeal Shockwave Therapy Is

The dermaPACE System is an advanced wound care device that utilizes pulsed acoustic cellular expression (PACE®) technology, a proprietary form of focused, extracorporeal shockwaves. Shockwave technology has been used for nearly 30 years in orthopedic treatments for pain, fractures, etc., and with lithotripsy for breaking kidney stones. The PACE shockwave technology has the level of energy deposited inside the tissue specifically tuned to promote tissue healing, without any detrimental effects to the delicate cellular structures from the wound bed, periwound, or deep behind the skin level.

The dermaPACE System offers an improved, noninvasive standard of care that may shorten an otherwise lengthy healing process. It is the first shockwave system to be FDA-cleared for the treatment of diabetic foot ulcers (DFU).*

Clinical Results1

A 336-subject randomized and double-blind clinical trial demonstrated superiority in wound healing and wound area reduction when comparing the dermaPACE System treated patients against the control patients, with an excellent safety profile. The dermaPACE System showed superior results vs. control:

  • In wound closure at 24 weeks (37.79% vs. 26.22%; p=0.023)
  • In the overall rate to wound closure (p=0.0346)
  • In the reduction in area (cm2) of the wound at six weeks (p=0.003) through 24 weeks (p=0.047)

Benefits of the dermaPACE System in Advanced Diabetic Wound Care

By activating the body’s normal regenerative process using high energy shockwaves, the dermaPACE System expedites healing at the cellular level. The system accelerates wound closure and re-epithelialization through increased perfusion via angiogenesis and neovascularization, with biofilm disruption that allows antibiotics to penetrate the wound.

The treatment helps modulate the inflammatory response, leading to altered cytokine and chemokine expression that initiates tissue healing and eliminates the chronicity cycle. At the same time, mechanical forces produced inside the tissue by the shockwaves upregulate multiple growth and tissue regeneration factors that ultimately produce angiogenesis, neovascularization, granulation, tissue regeneration, and healing. Learn more.

In general, only a few treatments lasting a few minutes are needed to jump-start the healing process and produce new, healthy tissue. Aftercare is simply the standard of wound care. Possible side effects include reddening, bruising, tingling, numbness or increased pain. Generally, however, the treatments are well-tolerated and do not interfere negatively with other passive or energy-based wound care technologies that might be applied in between the dermaPACE System treatment sessions.

For the healthcare provider, dermaPACE therapy is a financially viable solution that reduces financial impact both for the patient and the healthcare system. At the discretion of the wound care professional, it can be successfully combined with other standard or advanced wound therapies to accelerate wound healing.

The result? Less time and fewer resources spent on costly treatments that are less effective — and faster relief with a significantly increased quality of life for the patient.

*The dermaPACE System is CE-marked in Europe for application in acute and chronic defects of the skin and subcutaneous tissues. These include:

  • Post-operative wound healing defects
  • Post-traumatic wounds
  • Deep, partial-thickness burns
  • Decubitus ulcers (pressure ulcers)
  • Diabetic ulcers
  • Arterial ulcers
  • Venous ulcers
References

1. Phase III Pivotal Trial Results of dermaPACE for the Treatment of Diabetic Foot Ulcers. Data on file with SANUWAVE Health, Inc.