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

2. Prime Healthcare Shasta Regional Medical Center Wound Care Clinic

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

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

5. …27% require a 2nd amputation within the year
The Cost of Failure:
…27% require a 2nd amputation within the year

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

7. 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”?)

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

9. Diabetic Ulcer

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

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

13. Prime Healthcare Shasta Regional Medical Center Wound Care Clinic

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

15. 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

16. 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.

17. 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

18. 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.

19. 4/18/16 Tunnel present, I&D done at bedside

20. 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

21. 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.

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

24. Dermagraft is a 3-dimensional human dermal substitute1
References: 1. DERMAGRAFT Directions for Use. Organogenesis Marston WA, et al. Diabetes Care. 2003;26(6): Data on file. Shire Regenerative Medicine US Food and Drug Administration. Medical Devices. Premarket Approval. Accessed February 6, 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): Margolis DJ, et al. Diabetes Care.1999;22(5): Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S Gentzkow GD, et al. Diabetes Care. 1996;19(4):

25. 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 Marston WA, et al. Diabetes Care. 2003;26(6): Data on file. Shire Regenerative Medicine US Food and Drug Administration. Medical Devices. Premarket Approval. Accessed February 6, 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): Margolis DJ, et al. Diabetes Care.1999;22(5): Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S Gentzkow GD, et al. Diabetes Care. 1996;19(4):

26. 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 Marston WA, et al. Diabetes Care. 2003;26(6): Data on file. Shire Regenerative Medicine US Food and Drug Administration. Medical Devices. Premarket Approval. Accessed February 6, 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): Margolis DJ, et al. Diabetes Care.1999;22(5): Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S Gentzkow GD, et al. Diabetes Care. 1996;19(4):