T H E m e d i c al m a g a z i n e f o r u s e r s o f d e r m a g r aft ®
On
FA L L 2 0 0 9
Dermagraft
®
“Any wound that remains unhealed after 4 weeks is a cause for concern, as it is associated with worse outcomes, including amputations.”
–1999 Consensus Development Conference on Diabetic Foot Wound Care
INSIDE: Diabetic Limb Salvage ‘09
Dermagraft on Display in Washington, DC
Heal2gether & “Save A Leg, Save A Life” Team Up
Increasing Awareness of Chronic Wounds
A Team Approach to Wound Healing
Case Study & Interview with Advanced Wound Care Center
Driving the Standard of Care 4 Weeks – A Pivotal Clinical Decision Point
Make the Shift. Get your diabetic foot ulcer patients back into high gear.
Any wound that remains unhealed after 4 weeks is cause for concern, as it is associated with worse outcomes, including amputations. Make the shift to Dermagraft for faster healing times with clinically proven results. Dermagraft: Delivering living cell therapy.
visit us at www. dermagraft
CO V E R
Today, the Standard of Care for non-responding diabetic foot ulcers can be expressed in a single word: Dermagraft
®
Driving the Standard of Care Widely recognized as today’s most progressive treatment for diabetic foot ulcers, Dermagraft from Advanced BioHealing is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is currently FDA approved for the treatment of diabetic foot ulcers.
4 weeks - a pi votal c lin i c a l decision point in the c a re of dia betic foot ulc e r s
With over 150,000 applications to date, Dermagraft has become an integral part of the Standard of Care for diabetic foot ulcers and has enabled clinical professionals to make a profound difference in the lives of thousands of diabetic patients.
Diabetic Foot Ulcers FA L L 2 0 0 9
IND E X
On Dermagraft
I Driving te Standard of Care 3 I Diabetic Limb Salvage 2009 1
Heal2gether Teams Up
4
Study & Interview with I Case Advanced Wound Care
Center Team
DG-1077-02 ©2009 Advanced BioHealing, Inc. All Rights Reserved. Advanced BioHealing Inc. 10933 N. Torrey Pines Rd., Suite 200, La Jolla CA 92037 www.ABH.com
As a chronic medical condition among many diabetes patients, it is estimated that 15-25% will develop a foot ulcer in their lifetime, putting Black 7 them at a 14-24% risk for lower limb amputation, and a 45% chance of death within five years if not managed properly. In fact, risk of death from unhealed neuropathic ulcers, like diabetic foot ulcers, is greater than both breast cancer and prostate cancer combined. The primary goal in the treatment of diabetic foot ulcers is to obtain wound closure as quickly as possible. The faster the wound is healed, the less chance there is to develop infection, which can lead to severe, high cost procedures, including amputation. The cost associated with treating a diabetic foot ulcer is $39,000 (2009 U.S.) for the two years following diagnosis. However, that number increases significantly when the wounds are complicated by osteomyelitis,
a limb-threatening foot infection that costs $19,000 to $23,000 depending on antibiotics used, and amputation which can cost $70,000 to $103,000 depending on the severity. By closing non-healing diabetic foot ulcers with Dermagraft, physicians can not only achieve better outcomes and avoid severe wound complications, but also have the potential to save the healthcare system hundreds of thousands of dollars per patient.
4 Weeks A study conducted by Peter Sheehan, MD, found that patients in whom the diabetic foot ulcer size fails to reduce by over half in the first 4 weeks of treatment are unlikely to achieve wound healing over a reasonable period of 12 weeks. Therefore, the percent change in a patient’s diabetic foot ulcer at 4 weeks can be used as a “pivotal clinical decision point in the care of diabetic foot ulcers for early identification of patients who may not respond to [conventional wound] care and may need additional treatment.” The findings in this study can be extremely valuable in the costly and complicated management of diabetic foot ulcers. This information may enable early identification of patients who will require more aggressive treatments. In fact, several studies have since confirmed Dr. Sheehan’s findings that 4 weeks must be considered a critical decision point in the Standard of Care. As recently as February 2009, a study by David J. Margolis, MD, PhD, and colleagues, in Wound
Today’s most progressive treatment for diabetic foot ulcers, Dermagraft is a bio-engineered skin substitute
O n D e r m a gr a f t ® I FA L L 2 0 0 9 I w w w. d e r m a g r a f t . c o m
1
upcoming c o n fe r e n c e s
CO V E R
Driving the Standard of Care continued
Patients with hard-to-heal diabetic foot ulcers don’t have to face a debilitating future of chronic wounds and painfully slow healing
Superbones Conference January 14 – 17, 2010 Paradise Island, Bahamas
Florida Podiatric Medical Association – SAM 2010 January 20 – 24, 2010 Orlando, Florida
New York Podiatric Clinical Conference January 29 - 31, 2010 New York, New York
American College of Foot and Ankle Surgeons Scientific Conference February 22 – 26, 2010 Las Vegas, Nevada
2
Repair and Regeneration (2009), evaluating the use of prognostic information for the care of individuals with venous leg ulcers or diabetic neuropathic ulcers, “confirms recommendations… concerning the importance of evaluating prognostic information with respect to a patient’s treatment plan and the importance of using information on improvement within 4 weeks of initiation of care. It also validates… the usefulness of using change in wound size after 4 weeks of care as a surrogate market for a healed wound.” Also to be considered, a 2007 review of the optimal treatment strategy for diabetic foot ulcers in US Endocrine Review (2007; Spring), David G. Armstrong, MD, and colleagues concluded: “Arguably, the use of an active therapy such as a bio-engineered skin substitute to stimulate healing in non-responding wounds after 4 weeks’ treatment is the optimal care…” Even more specifically, they found “excellent success using…Dermagraft to accelerate the healing of [diabetic foot ulcers].”
putting their patients at a higher risk for poor outcomes, including amputation.
Adoption of the Standard of Care Adoption of Dermagraft as the Standard of Care is increasing rapidly, as evidenced by the number of units of Dermagraft sold over the past two and a half years. To date, more than 150,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. Since Advanced BioHealing began manufacturing Dermagraft in 2007, the number of units purchased by medical professionals in the U.S. has skyrocketed from just more than 500 units in the first quarter of 2007 to more than 5,000 units in the first quarter of 2008 and more than 10,000 units in the first quarter of 2009 [see chart below]. So far in 2009 alone, more than 40,000 pieces of Dermagraft have been applied to patients with diabetic foot ulcers, and that number is expected to increase by more than half again by year-end.
Dermagraft Patients with hard-to-heal diabetic foot ulcers don’t have to face a debilitating future of chronic wounds and painfully slow healing because Dermagraft is changing the way the world heals chronic wounds. When implanted into an adequately prepared diabetic foot ulcer, Dermagraft assists in the restoration of the dermal bed allowing the patient’s wound to heal (re-epithelialize). In a pivotal trial, Dermagraft increased the proportion of diabetic foot ulcers that heal at 12 weeks by 64% when compared to conventional therapy. Just as there’s a national standard of care for diseases such as breast and prostate cancer, there is a Standard of Care for treating diabetic foot ulcers, and physicians who are not following the new Standard of Care may be
Advanced BioHealing firmly believes that as more medical professionals become knowledgeable and committed to today’s Standard of Care for diabetic foot ulcers, patients can look with much greater hope towards a future of complete healing and resumption of their normal activities. Join us in driving the Standard of Care and help provide the gift of healing with Dermagraft.
O n D e r m a g r a f t ® I FA L L 2 0 0 9 I w w w. d e r m a gr a f t . c o m
Dermagraft and Standard of Care on Display at
Diabetic Limb Salvage 2009 Advanced BioHealing, dedicated to helping medical professionals address diabetic foot ulcers with the most appropriate treatment and advanced technology possible, has been a proud sponsor of the Georgetown University Hospital’s Diabetic Limb Salvage Conference since it began three years ago. The 2009 conference, which was recently held in Washington, DC, saw significant increase in attendance as diabetic foot ulcers are beginning to gain recognition as a major disease category for the most sick and high risk diabetic patients. The high cost associated with treatment for such complications is also becoming more widely known. Dermagraft and the Standard of Care for nonresponding diabetic foot ulcers were highlighted in a number of presentations throughout the conference. Dermagraft was featured in a live limb salvage case demonstration and hands-on workshop by John S. Steinberg, DPM, Assistant Professor at Georgetown University
and Co-Director of the University’s Center for Wound Healing in Washington, DC. The Standard of Care for non-responding diabetic foot ulcers were addressed in case studies delivered by some of the industry’s finest opinion leaders, including Robert Kirsner, MD, PhD, Professor and Vice Chairman in the Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine, Director of the University of Miami/Cedars Wound Center and Co-director of the Symposium for Advanced Wound; and Robert Snyder, DPM, CWS. Dr. Kirsner delivered a very compelling presentation which advocated for a new Standard of Care around bioengineered products, specifically mentioning Dermagraft. Dr. Snyder presented a poster abstract in which investigators found that 95% of patients with DFUs that failed to heal by 12 weeks did not first achieve at least 50% wound closure after the first 4 weeks of conventional treatment.
Heal2gether Teams Up with “Save A Leg, Save A Life” Foundation The Heal2gether Partnership Program is pleased to announce a collaborative effort with the “Save A Leg, Save A Life” Foundation to deliver our shared mission of increasing awareness of chronic wounds and improving the quality of life for those afflicted with such complications. Heal2gether is a Partnership Program designed to improve wound healing outcome, as well as, increase awareness of diabetic foot ulcers via patient adherence and community outreach efforts. Similarly, SALSAL is a non-profit, grass-roots organization seeking to reduce the number of lower extremity amputations and improve the prognosis while striving to ensure a better quality of life for people suffering from diabetic foot ulcers or Peripheral Artery Disease (P.A.D.). The first collaborative effort included a Screening for residents of the Orlando, Florida area on October 8th during the recently held First Annual SALSAL Foundation National meeting. Blood glucose and foot sensory screenings were included in the day’s event. Participants in the screening also received “goodie bags” with information pertaining to diabetes, P.A.D. and wound care. Heal2gether and SALSAL are in the process of taking our efforts to “the streets” in 2010 via mobile community outreach. Using a mobile medical unit, we plan to hold community screenings in locations across the U.S. where SALSAL Chapters have been established. O n D e r m a gr a f t ® I FA L L 2 0 0 9 I w w w. d e r m a g r a f t . c o m
3
i n te r v i ew
Dr. William C. James, III, MD; Dr. Robert Santrock, MD; and Ms. Jessamyn Deemer, PA (pictured below L-R) are an orthopaedic foot and ankle team at Advanced Wound Care Center in Columbia, South Carolina. The team specializes in the comprehensive care of diabetic patients and uses a team approach to wound healing that includes the use of all advanced wound modalities. Dermagraft has been a useful adjunct in their wound healing arsenal. “We have found Dermagraft to be an outstanding modality to refractory wounds,” said Dr. James. “Its unique biological qualities make it an ideal option for the types of wounds we see.” “When we have a wound that has stalled and is free of infection, we will often use Dermagraft,” said Dr. Santrock. “This biological treatment creates the stimulus needed to advance the healing process in most of our diabetic foot ulcerations and complicated cases.”
A Team Approach to Wound Healing Interview with Advanced Wound Care Center Orthopaedic Foot & Ankle Team “If the mechanics and vascularity are accounted for and infection is absent, Dermagraft will often create a successful healing pattern,” further explained Ms. Deemer. This is evidenced by the team’s success in healing an ulceration that one specific patient had for greater than a year, after just eight weeks of Dermagraft therapy.
“This biological treatment creates the stimulus needed to advance the healing process”
Dr. James and Dr. Santrock are members of the American Academy of Orthopaedic Surgeons, American Orthopaedic Foot and Ankle Society, as well as, the American Medical Association. Drs. James and Santrock also hold the title of Associate Professor, Department of Orthopaedic, with the University of South Carolina’s School of Medicine. Advanced Wound Care Center was opened by Midlands Orthopaedics in March of 2007.
4
O n D e r m a g r a f t ® I FA L L 2 0 0 9 I w w w. d e r m a gr a f t . c o m
case study
Pr es ente d by: T he Adva nc ed Wound Ca re Cente r at Midlands O rthopae dics
Dermagraft Case Study 速
Week 1 1st Dermagraft Application Wound Size: 2.2cm x 2.3cm x .02cm
Patient History The female patient has a history significant for diabetes and MRSA.
Current Diagnosis 1 year old diabetic ulcer
Wound Treatment & Outcome Week 3 3rd Dermagraft Application Wound Size: 2cm x 2.2cm x .02cm
Week 6 6th Dermagraft Application Wound Size: 1.2cm x .09cm x .01cm
The patient was previously treated at several other facilities. Most recently, the patient has used duoderm, acticoat and wet to dry. At onset, the center used a total contact cast (TCC). Once concern for infection was no longer present and the patient had made limited gains with advanced treatments, the center turned to Dermagraft. She came in for weekly applications of Dermagraft. 40% of the time she was treated with a TCC along with Dermagraft. Standard treatment and application techniques were used. After 8 weeks of Dermagraft the ulceration she had for greater than one year was healed.
Week 8 Healed
O n D e r m a gr a f t 速 I FA L L 2 0 0 9 I w w w. d e r m a g r a f t . c o m
5
De r m a g r aft Re i m b u r s e m e n t H o tl i n e
Verification of Benefits for your patient is just a phone call away You can know the details of Dermagraft payment before you order. The Dermagraft Reimbursement Hotline will provide answers to your questions: Coding: Coverage: Payment:
What codes are required for processing the claim? Does the patient’s insurer cover Dermagraft? Is there a co-pay or deductible? What does the insurer pay for Dermagraft and the related codes?
Dermagraft Reimbursement Hotline
1-866-866-7731 Or FAX your Insurance Verification Request to 1-866-866-7713 Your Sales Rep can provide you with the form you need for faxing as well.
De r m a g r aft C u s t o m e r A s s i s ta n c e
Need Help? We’re here to answer your questions!
• Product Orders
• Technical Support
• Product Questions
• Reimbursement Information
Customer Assistance
1-877-DERMAGRAFT (1-877-337-6247)