The U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.
The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2(about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.
dermaPACE is CE Marked for the application of pulsed acoustic waves on acute and chronic defects of the skin and subcutaneous soft tissues, e.g.
- Post-operative wound healing defects
- Post-traumatic wounds
- Deep-partial thickness burns
- Decubitus ulcers
- Diabetic ulcers
- Arterial ulcers
- Venous ulcers
The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.
The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.
The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever.
What to Expect During a dermaPACE Treatment
The treatment takes place at your physician’s office or healthcare facility at a scheduled time. You should wear loose-fitting clothing or you may be asked to change into a hospital gown. On the treatment day you should be in overall good health. Before treatment you will be informed of the procedure and asked to sign an informed consent form.
The procedure will begin with the removal of dressings or bandages from the wound. The edges of the wound may be measured to determine the size of the wound. The wound will be gently cleansed, and sterile gel will be applied to the wound. The dermaPACE Applicator will be gently applied to the wound surface, and treatment will begin. The device makes an audible “popping” sound that will last until the treatment ends. In general only a few treatments lasting a few minutes are needed; however, the treatment time – as well as the number of treatments – depend on the wound condition. After treatment, you will receive standard wound care including a dressing and other instructions from your medical professional. You will receive post-operative instructions from your physician following your procedure, which means you should be an active participant in wound care.
What if I have a Special Health Condition?
The safety and effectiveness of PACE procedures has not yet been determined in people with the following health conditions. Your doctor will provide you with information about how these and other health conditions might affect the outcome of a PACE procedure.
- Malignancies in the treatment area
- Treatments in the head area
- Treatments on the spinal column
- Treatments in the lung area
- Treatments in the area of the gonads
- Coagulation disorders
The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA’s 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device.
The FDA permitted marketing of the Dermapace System to Sanuwave, Inc.