ESWT (Extracorporeal Shock Wave Therapy) for the treatment of chronic wounds
Suggested Treatment Protocol
Treatment will be performed once a week for three weeks until and including the third week and then once in two weeks up to an additional 6 weeks (total of 9 weeks) or until wound closure is achieved (a total of 6 treatment sessions; Minimum treatment sessions will be three and maximum treatment sessions will be 6).
All treatment sessions will be given to the subject by trained personnel.
1. The treated limb is being laid comfortably on the treatment surface.
2. Perform standardized wound cleaning and if required, a standardized wound debridement.
3. The wound area is covered with a sterile cover film (for example Incise drape manufactured by 3M company or OpSite incision film from Smith & Nephew or any equivalent product)
4. Sterile ultrasound gel is being generously spread over the covered ulcer.
5.Spread an additional generous layer of sterile US gel over the Omnispec device applicator
6. Put the Omnispec device applicator over the gel-covered ulcer.
7. The wound area will be divided into treatment locations each with an area of 1.5 cm2. The total amount of SW per treatment wound will be determined as follows: (Maximal wound area in cm2* 20) + 350=total number of SW per treatment of the whole wound. The number of SW per treatment location will be the calculated total number of SWs per wound divided by the number of treatment locations.
8. Each treatment location will be given the calculated number of SWs at a frequency of 2 Hz. A treatment location will be defined as an area of 1.5 cm2. The treatment will be applied to each 1.5 cm2of the wound and its surrounding area as described in the illustration below (Fig 1).
9. Additionally, a total of 2400shocks will be applied to the plantar area of the foot along the course of the plantar main arteries as illustrated in figure 2.
10. Remove plastic film and coupling gel
11.Clean wound with sterile saline solution
12.Apply standardized dressing as required by the individual healing phase
Total number of treatments: Suggested number of treatments 3-6 according to the clinical progression.