NovaWave – ES accelerates healing of decubitus ulcers resulting from diminished circulation in conditions such as Diabetes

NovaWave ElectroStimulation … for wound healing
Wounds
In a typical hospital 25% to 40% of beds will be occupied by patients with wounds. Various types of wounds take up over half of all resources, Posnett, J., Franks, P.J, (2008). Chronic wounds are strongly correlated with age. The human cost of wounds is measured in pain, distress, embarrassment, anxiety, prolonged hospital stays, chronic morbidity or even death. The resource impact on health-care providers is equally important. Wound complications are associated with longer and more intensive treatment, extended hospital stays, readmission and specialist medical or surgical intervention. The need for a clinically proven method to speed up the healing of wounds is clear.

Mechanisms
Chronic wounds, including venous, arterial and diabetic ulcers often have impaired blood flow.
Studies indicate that increased blood circulation results in improved wound healing.
Increasing blood circulation increases Transcutaneous Oxygen Tension (TCpO2)8 which is a predictor of tissue viability and ischemic wound healing.
Electrostimulation (ES) is effective at both the cellular and biochemical level. Gentzkow G.D. (1993) Electrical stimulation to heal dermal wounds. J. Dermatol. Surg. Oncol. 19, 753-758. It will improve blood flow and tissue oxygenation at the wound site, Thakral et al, comment that “electrical stimulation appears to be a perfect adjunctive therapy.”

NovaWave ElectroStimulation Therapy
The NovaWave ElectroTherapy System is a biomedical device designed to accelerate healing of decubitus ulcers. The patented electrostimulation waveform delivers a series of frequencies to the ulcer site promoting blood flow, anti-bacterial effect and increased ATP production. Treatment is administered through reusable custom fit carbon rubber electrodes to prevent direct contact to an open wound.

Current Wound Care Costs
The study “An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds” analyzed 2014 Medicare data and determined the cost of chronic wound care for Medicare beneficiaries in aggregate, by wound type, and by setting. The findings are compelling:
Chronic non-healing wounds impact nearly 15% of Medicare beneficiaries (8.2 million).
A conservative estimate of the annual cost is $28 billion when the wound is the primary diagnosis on the claim. When the analysis included wounds as a secondary diagnosis, the cost for wounds is conservatively estimated at $31.7 billion.
• Surgical wounds and diabetic foot ulcers drove the highest total wound care costs (including cost of infections).
• On an individual wound basis, the most expensive mean Medicare spending per beneficiary was for arterial ulcers followed by pressure ulcers.
• Hospital outpatient services drove the greatest proportion of costs – demonstrating a major shift in site-of-service costs from hospital inpatient to outpatient settings.
• Surgical infections were the largest prevalence category, followed by diabetic wound infections.
If in-patient treatment episodes are required then additional costs escalate very rapidly.
NovaWave ElectroTherapy treatment will reduce healing time by 50% on average and will usually prevent escalation into more complex and costly treatment.

References
1. Monaco, J.L.; Lawrence, W.T. Acute wound healing: An overview. Clin. Plast. Surg. 2003, 30, 1–12.

2. Greaves, N.S.; Iqbal, S.A.; Baguneid, M.; Bayat, A. The role of skin substitutes in the management of chronic cutaneous wounds. Wound Repair Regen. 2013, 21, 194–210.

3. Fonder, M.A.; Lazarus, G.S.; Cowan, D.A.; Aronson-Cook, B.; Kohli, A.R.; Mamelak, A.J.
Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J. Am. Acad. Dermatol. 2008, 58, 185–206.

4. Singh, A.; Halder, S.; Chumber, S.; Misra, M.C.; Sharma, L.K.; Srivastava, A. Meta-analysis of randomized controlled trials on hydrocolloid occlusive dressing versus conventional gauze dressing in the healing of chronic wounds. Asian J. Surg. 2004, 27, 326–332.

5. Posnett, J.; Franks, P.J. The burden of chronic wounds in the UK. Nurs. Times 2008, 104, 44–45.

6. Mustoe, T.A.; O’Shaughnessy, K.; Kloeters, O. Chronic wound pathogenesis and current treatment strategies: A unifying hypothesis.  Plast. Reconstr. Surg. 2006, 117, 35S–41S.

7. Vileikyte, L. Diabetic foot ulcers: A quality of life issue. Diabetes Metab. Res. Rev. 2001, 17, 246–249.

8. Amsler, F.; Willenberg, T.; Blättler, W. In search of optimal compression therapy for venous leg ulcers: A meta-anlysis of studies comparing divers bandages with specially designed stockings.
J. Vasc. Surg. 2009, 50, 668–674.

9. Carter, J.M.; Tingley-Kelley, K.; Warriner, I.R.A. Silver treatments and silver-impregnated dressings for the healing of leg wounds and ulcers: A systematic review and meta-analysis. J. Am. Acad. Dermatol. 2010, 63, 668–679.

10. Armstrong, D.G.; Marston, W.A.; Reyzelman, A.M.; Kirsner, R.S. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: A multicenter
randomized- controlled trial. Wound Repair Regen. 2011, 19, 173–180.

11. Cullum, N.A.; Al-Kurdi, D.; Bell-Syer, S.E. Therapeutic ultrasound for venous leg ulcers.
Cochrane Database Syst. Rev. 2010, doi:10.1002/14651858.CD001180.pub3.

12. Dumville, J.C.; Worthy, G.; Soares, M.O.; Bland, J.M.; Cullum, N.; Dowson, C.; Iglesias, C.; McCaughan, D.; Mitchell, J.L.; Nelson, E.A.; et al. VenUS II: A randomised controlled trial of larval therapy in the management of leg ulcers. Health Technol. Assess. 2009, 13, 1–206.

13. Greaves, N.S.; Benatar, B.; Baguneid, M.; Bayat, A. Single-stage application of a novel decellularized dermis for treatment-resistant lower limb ulcers: Positive outcomes assessed by SIAscopy, laser perfusion, and 3D imaging, with sequential timed histological analysis.
21, 813–822.

14. Snyder, R.J.; Kirsner, R.S.; Warriner, R.A.; Lavery, L.A.; Hanft, J.R.; Sheehan, P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manag. 2010, 56, S1–S24.

15. Suh, H.; Petrofsky, J.; Fish, A.; Hernandez, V.; Mendoza, E.; Collins, K.; Yang, T.; Abdul, A.; Batt, J.; Lawson, D. A new electrode design to improve outcomes in the treatment of chronic non-healing wounds in diabetes. Diabetes Technol. Ther. 2009, 11, 315–322.

16. Petrofsky, J.; Lawson, D.; Prowse, M.; Suh, H.J. Effects of a 2-, 3- and 4-electrode stimulator design on current dispersion on the surface and into the limb during electrical stimulation in controls and patients with wounds. J. Med. Eng. Technol. 2008, 32, 485–497.

17. Jünger, M.; Arnold, A.; Zuder, D.; Stahl, H.W.; Heising, S. Local therapy and treatment costs of chronic, venous leg ulcers with electrical stimulation (Dermapulse): A prospective, placebo controlled, double blind trial. Wound Repair Regen. 2008, 16, 480–487.

18. Isseroff, R.R.; Dahle, S.E. Electrical stimulation therapy and wound healing: Where are we now?
Adv. Wound Care 2012, 1, 238–243.

19. Reger, S.I.; Hyodo, A.; Negami, S.; Kambic, H.E.; Sahgal, V. Experimental wound healing with electrical stimulation. Artif. Organs 1999, 23, 460–462.

20. Gagnier, K.A.; Manix, N.; Baker, L. The effects of electrical stimulation on cutaneous oxygen supply in paraplegics. Phys. Ther. 1988, 68, 835–839.