Prime Healthcare Shasta Regional Medical Center Wound Care Clinic The Art & Science of Diabetes Symposium 2017

Prime Healthcare Shasta Regional Medical Center Wound Care Clinic

The Cost of Failure: 20% will develop a wound… … 20 % of whom will develop a wound in there lifespan… 20% will develop a wound…

…increasing their risk of amputation by 46% The Cost of Failure: …increasing their risk of amputation by 46%

…27% require a 2nd amputation within the year The Cost of Failure: …27% require a 2nd amputation within the year

…and 50% are dead 5 years later The Cost of Failure: …and 50% are dead 5 years later

By the Numbers… Chronic wounds affect 6.5 million Americans/ year at a treatment cost of $25 billion per year Additional $39 billion in lost wages/ year $15.3 billion estimated expense on wound care products in 2010 To answer this question, we simply need to do a little math… (the cost of “success”?)

Diabetic Ulcer Location: plantar aspect of the foot beneath a bony prominence. Appearance: ill-defined borders, prominent callus, and palpable pulses.

Diabetic Ulcer

DFU- Management Principles Off-loading Debridement/ dressing selection (clean, moist wound bed) Evaluate and correct ischemia/osteomyelitis Adjunctive therapy Skin substitutes HBOT

Skin Subsitutes Bio-Engineered Collagen Wound Matrix Apligraf Dermagraft Collagen Wound Matrix Oasis Puraply Amniotic Membrane Allografts Grafix EpiFix

Prime Healthcare Shasta Regional Medical Center Wound Care Clinic

Case Study’s First visit to the Wound Center 11/21/14

12/9/14 Pt came to the WCC with the wound below. Patient was then readmitted for cellulitis and possible associated osteomyelitis and for IV antibiotic and further management. On 12/16/2016 was transferred to Vibra. 12/9/14

5/5/2015 - Again admitted to the hospital with DFU and Cellulitis of the right foot. 8/20/15 – Admitted for heart failure 2/8/16 – Sepsis from DFU right foot, pt refuses BKA.

9/10/16 – Sepsis from DFU right foot, again refuses BKA. 9/14/16 Surgical debridement in the OR 9/9/16 After surgical debridement in the OR. Pt back at home. Continue to follow in WCC. 9/26/16

First Visit 4/11/16 for DFU Past Medical History: : CVA/TIA/Stroke, Coronary Artery Disease, Diabetes, Gout, High Cholesterol, Hypertension, Leukemia, Myocardial Infarction, Charcot foot Past Surgical History: Angioplasty, Coronary bypass surgery, Orthopedic surgeries foot surgery and History of osteomyelitis, status post tarsal amputation of the right foot.

4/18/16 Tunnel present, I&D done at bedside

New wound dorsal left foot communicates with plantar wound 4/28/16 New wound dorsal left foot communicates with plantar wound 5/5/16 I&D done from Left dorsal foot wound to plantar wound

5/31/16 Clean and granulating 1st Cellular Tissue product used Total of 6 applied through 8/16/16 9/27/16 7/19/16 Total contact casting started and done weekly.

DFU 8/21/14 12/7/15 8/7/15

Dermagraft is a 3-dimensional human dermal substitute1 References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003;26(6):1701-1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002;10(suppl A):6A-13A. 6. Loots MAM, et al. J Invest Dermatol. 1998;111(5):850-857. 7. Margolis DJ, et al. Diabetes Care.1999;22(5):692-695. 8. Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S209. 9. Gentzkow GD, et al. Diabetes Care. 1996;19(4):350-354.

Chronic diabetic foot ulcers (DFUs) demonstrate impaired healing that results from multiple pathological factors (eg, vascular insufficiency, altered cellular activity, and a dysfunctional extracellular matrix), leading to a deficient wound bed, which often fails to respond to conventional therapy alone5-7 Dermagraft helps to restore the compromised DFU dermal bed to facilitate healing by providing a substrate over which the patient’s own epithelial cells can migrate to close the wound5 Composed of human fibroblasts, an extracellular matrix, and a  bioabsorbable polyglactin mesh scaffold1 Cryopreserved, 3-dimensional, human dermal substitute1 Allows for serial applications without the need for removal of the product from the wound1 References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003;26(6):1701-1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002;10(suppl A):6A-13A. 6. Loots MAM, et al. J Invest Dermatol. 1998;111(5):850-857. 7. Margolis DJ, et al. Diabetes Care.1999;22(5):692-695. 8. Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S209. 9. Gentzkow GD, et al. Diabetes Care. 1996;19(4):350-354.

Product quality specifications and cryopreservation Prior to release, each lot of Dermagraft must pass USP sterility (14-day), endotoxin, and mycoplasma tests; each lot meets release specifications for collagen content, DNA, and cell viability1 The human fibroblast cells are from a qualified cell bank1 Manufactured with sterile components under aseptic conditions within the final package1 Dermagraft must be stored continuously at -75°C ± 10°C1 and has a shelf-life of up to 6 months from the time of cryopreservation3 Cryopreservation enables testing prior to shipment and helps with inventory control5 Supplied frozen in a clear pouch containing one piece of approximately 2 in × 3 in (5 cm × 7.5 cm) for a single-use application1 To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold Dermagraft at room temperature for more than 30 minutes1 References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003;26(6):1701-1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002;10(suppl A):6A-13A. 6. Loots MAM, et al. J Invest Dermatol. 1998;111(5):850-857. 7. Margolis DJ, et al. Diabetes Care.1999;22(5):692-695. 8. Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S209. 9. Gentzkow GD, et al. Diabetes Care. 1996;19(4):350-354.