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T H E me d i c a l m a g a z i n e f o r users o f d erm a g r a f t 速


Have You Seen the

number 4? An aggressive approach

On SUMMER 2009


Case Study & Interview with Jonathan W. Strong, DPM

Partnering with Patients to

Overcome Adherence Challenges

Juggling the everyday aspects of your patient’s life can make caring for a diabetic foot ulcer seem overwhelming.

Heal2gether can help. “How will my patient fit all my suggestions into their daily routine?” “How will I know if the patient is doing everything needed to speed healing?”

Tell your patients how the Heal2gether Partnership Program can help. FREE Diabetic Foot Ulcer Kit available for patients. Call 858-754-3881 for participation information or visit


Heal2gether Partnership Program

Industry’s First Patient Adherence Program for Diabetic Foot Ulcer Treatment The Heal2gether mo b i l e van is used a t se n i o r center s and health f a i r s

J U LY 2 0 0 9


On Dermagraft


with Patients I Partnering to Overcome Adherence Challenges




Case Study & Interview with I Jonathan W. Strong, DPM

Have You Seen the Number 4?

©2009 Advanced BioHealing, Inc. All Rights Reserved. Advanced BioHealing Inc. 10933 N. Torrey Pines Rd., Suite 200, La Jolla CA 92037

Advanced BioHealing, Inc. (ABH), the makers of Dermagraft®, a cryopreserved human fibroblast-derived dermal substitute indicated for use in the treatment of chronic fullthickness diabetic foot ulcers (DFUs) greater than 6 weeks duration, recently announced the initiation of the Heal2gether Partnership Program. Heal2gether is a Patient Adherence Program designed to increase awareness of DFUs, enhance the effectiveness of Dermagraft in healing DFUs, and encourage patient adherence throughout the treatment process. There are two parts to the Heal2gether Partnership Program: • The first is a managed patient support program that focuses on encouraging patients to adhere to the Black 7 acceptance, access and action phases of DFU treatment. • The second is a community outreach program that aims to help those at risk of developing the condition to learn why they need to take special care of their feet, how to identify the early warning signs, and how to prevent them in the future. Since its approval by the Food and Drug Administration (FDA) in 2001, thousands of DFU patients have been successfully treated with Dermagraft. The effectiveness of treating DFUs depends on the patient’s understanding of the gravity of the condition and their dedication to adhering to the treatment plan designed by the treating physician.

For the use of Dermagraft, this includes attending weekly medical appointments and limiting weight bearing activity on the treated foot.

Patient Support Program The Heal2gether Partnership Program, which is free to the patient, is a phone-based program designed to provide patients with support, guidance, and encouragement to help them manage their diabetes and work towards healing their DFU. Through this program, patients are paired with a licensed social worker with extensive experience in motivational interviewing. As the patient’s personal treatment partner, the social worker will help and encourage the patient through every step of the healing process and will provide physicians with consultation summary reports that inform them about their patient’s progress in the adherence program. “Treatment of diabetic foot ulcers requires steadfast adherence on behalf of the patient,” said Steve Bohannon, RN, Program Director at Providence Wound Care Clinic. “A process that encourages patients to maintain their dedication to the treatment program is invaluable in our ability to provide our patients with the best care possible.” “Unlike similar patient adherence programs provided by pharmaceutical companies that are based on either scripted conversations or impersonal electronic interactions, the

A phone-based support program designed to provide patients with support, guidance, & encouragement

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up c o m i n g c o n f ere n c es

Visit the Dermagraft booth at these 2009 events:


Partnering with Patients to Overcome Adherence Challenges


2009 American Podiatric Medical Association (APMA) Annual Scientific Meeting July 30 – August 2 Toronto, ON Insights & Advancements in Foot & Ankle Surgery September 11 – 13 Atlantic City, NJ Diabetic Limb Salvage 2009 September 24 – 26 Washington, DC Reconstructive Surgery of the Foot and Ankle, Update 2009 October 1 – 4 San Diego, CA

“...many people become overwhelmed, frustrated and discouraged by the daily hassles of diabetes and by the unending, often burdensome selfcare demands” Heal2gether Partnership Program is the first patient adherence program that focuses on open, conversational dialogue between the patient and their treatment partner,” said Dean Tozer, Senior Vice President at Advanced BioHealing, Inc. “The Program emphasizes relationship building between the two parties with the goal of providing support to both patients and physicians in the healing process.” Through participation in this program, patients receive: • Weekly consultation calls by social workers • Educational brochures on DFUs • Journals to record their weekly goals • Toll-free telephone number to reach their designated social workers

Community Outreach Program 23rd Annual Clinical Symposium on Advances in Skin & Wound Care: The Conference for Prevention & Healing October 21 – 25 San Antonio, TX


Approximately 15 percent of people with diabetes will develop a foot ulcer during their lifetime, according to the International Diabetes Federation. However, many DFU patients in the U.S. do not currently receive advanced treatments for their foot condition. Key challenges contributing to this include: patient’s lack of knowledge and appreciation of the DFU condition and physicians’ concerns over a patient’s ability to adhere to advanced DFU treatments.

The Heal2gether community outreach program takes a grassroots approach to combating these challenges by increasing awareness of DFUs among the senior and diabetic populations. Through organizing and participating in a variety of events, including foot and glucose screenings in the Heal2gether mobile van at senior centers and health fairs, sponsoring presentations about DFUs and good foot care by podiatrists at community luncheons, and placing informative articles about DFUs in local senior and healthcare magazines, Heal2gether is raising visibility of the condition, one community at a time. “While medical treatments can solve many complications related with diabetes, many people become overwhelmed, frustrated and discouraged by the daily hassles of diabetes and by the unending, often burdensome selfcare demands,” said Dr. Susan Guzman, Psychologist at Behavioral Diabetes Institute (BDI), a non-profit organization dedicated to tackling the unmet psychological needs of people with diabetes. “By emphasizing education about diabetic foot ulcers and developing the relationship between the social worker and the patient, the Heal2gether Partnership Program is addressing both the physical and emotional aspects critical for short-term healing and long-term success living with diabetes.” The Heal2gether patient support and community outreach programs are being rolled out at multiple Wound Care Clinics in Dallas and Fort Worth, Texas, and are planned to launch in other cities over the coming months. For more information or to enroll your Wound Care Clinic in the Heal2gether Partnership Program, please contact Mary Shiratori ( Dermagraft, approved by the FDA in 2001, was acquired by ABH in 2006 and has been marketed by the Company since February, 2007.  

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Have You Seen the Number 4? Over the past several months, Dermagraft representatives, physicians and nurses throughout the country have been donning pins with the number “4”. Perhaps you’ve even seen them in your clinic. These pins are part of a campaign launched by Dermagraft to encourage physicians and nurses to closely monitor the healing process of their diabetic patients’ foot ulcers throughout the first 4 weeks of treatment. Due to the chronic nature of the diabetic foot ulcer (DFU), the wounds often do not respond to traditional wound care treatments, and may result in wound area infection and possible amputation.

achieve wound healing over a reasonable period of 12 weeks. This can be extremely valuable in the costly and complicated management of DFUs and may enable early identification of patients who will require more aggressive treatments.

Standard of Care The primary goal in the treatment of DFUs is to obtain wound closure as quickly as possible. The faster the wound is healed, the less chance there is to develop an infection, which carries with it the risk of amputation.

For this reason, if the wound remains unhealed after 4 weeks of conventional therapy, Dermagraft advocates physicians and nurses to adopt a standard of care for treating DFUs that takes a more aggressive approach to healing.

As Dr. Sheehan’s study found, if traditional wound care treatment has not healed a patient’s DFU by at least 50 percent by the fourth week of conventional therapy, it is critical that the patient receive advanced therapy to help encourage faster healing.

Why 4 Weeks?

Dermagraft, a cryopreserved human fibroblastderived dermal substitute, is one such advanced therapy. When implanted into an adequately prepared DFU, Dermagraft assists in the restoration of the dermal bed allowing the patient’s wound to heal (re-epithelialize). Since its approval in 2001, thousands of DFU patients have successfully been treated with Dermagraft, which is indicated for use in the treatment of chronic full-thickness DFUs greater than six weeks duration.

A study conducted by Peter Sheehan, MD found that the percent change in the wound area of DFUs over a 4-week period can strongly predict complete wound healing at 12 weeks.1 By examining absolute change in ulcer area at 4 weeks, researchers found that the change was significantly greater in patients whose wound healed versus those whose did not. As such, they were able to distinguish between patients in whom healing would be difficult from those who would heal readily with good standard care. These findings indicate that the percent change in the patient’s wound 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 standard care and may need additional treatment.” Therefore, the study concluded, patients in whom ulcer size fails to reduce by half over the first 4 weeks of treatment are unlikely to

What’s at Stake? Of the nearly 190 million people worldwide with diabetes who do develop a DFU, 14 to 24 percent will require an amputation.2 Further still, the relative five-year mortality rate after limb amputation is at least 50 percent. When compared with cancer, it is second only to lung cancer (86 percent). 1

Name: Why 4 Weeks? Last Seen: On the lapels of your Dermagraft representatives, physicians and nurses. Description: “Why 4 Weeks” is a campaign launched by Dermagraft to encourage physicians and nurses to adopt a standard of care for treating diabetic foot ulcers if the wound remains unhealed after 4 weeks of conventional therapy. If Found: Please contact your local Dermagraft rep or call (877) DERMAGRAFT for more information. “ Any wound that remains unhealed after 4 weeks is cause for concern, as it is associated with worse outcomes, including amputation.” – American Diabetes Association Consensus Development Conference on Diabetic Wound Care

For more information, please visit:

Sheehan P, Jones P, Caselli A, Giurini JM, Veves A. Percent change in wound area of

diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in 12-week prospective trial. Diabetes Care. 2003;26(6):1879-1882.


Armstrong, et al, International Wound Journal, 2007 Amer Cancer Society; Facts & Figures 2000 Singh, Armstrong, Lipsky et al. J Amer Med Assoc 2005 CLINICAL RESEARCH PARTICIPATION

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i n terv i ew

Jonathan W. Strong, DPM Jonathan W. Strong, DPM has been practicing podiatry since 2000, when he graduated from the College of Podiatric Medicine and Surgery at Des Moines University. When it comes to diabetic foot ulcer (DFU) wound care, his first priority is to help save limbs, and as demonstrated by this case study, he has been successful in doing so with the help of Dermagraft®. Dr. Strong, who estimates that 40 percent of his patient base is DFU cases, has adopted a fairly aggressive approach to healing DFUs. His philosophy for treating DFUs is deeply influenced by studies indicating that for wounds not showing any signs of healing by 30 days (or 4 weeks), more aggressive measures need to be taken. It is with this in mind that Dr. Strong does weekly applications of Dermagraft on an average of 16 patients per month.

An Aggressive Approach Case Study & Interview with Jonathan W. Strong, DPM B Y L i n d sey H a rt

“Studies show that if a wound isn’t showing any signs of healing by 30 days, that something needs to be done; that’s what really changed my theory on being more aggressive and going to Dermagraft vs. continuing on with local wound care.” “I see a lot of success in using Dermagraft where wounds have been present sometimes for several months and aren’t healing with conventional wound care methods,” said Dr. Strong. “When patients come to me and we use the appropriate measures for healing— offloading and proper debridement, combined with Dermagraft—we have success in healing the wound.” Dr. Strong completed his residency at Trinity Regional Medical Center in Fort Dodge, Iowa and is currently in private practice in Jefferson City, Missouri. He is also a staff member of St. Mary’s Wound Center in Jefferson City, Missouri and is faculty for the family medicine residency program at Capital Region Medical Center.


O n D e r m a g r a f t ® I S U M M E R 2 0 0 9 I w w w. d e r m a gr a f t . c o m

c a se stu d y

Dermagraft Case Study 速

P rese n te d by : J o n a th o n W. S tr o n g , D P M

Patient History

Wound Treatment & Outcome

Patient is a white male, 78 years of age. Patient has Type II diabetes with neuropathy, end stage renal disease on hemodialysis, hyperlipidemia, and hypertension. Patient is a non-smoker.

02/27/08 Wound was cleansed and prepped,

1st Dermagraft application

03/05/08 Wound has 90% granulation tissue; wound cleansed

and prepped, 2nd Dermagraft application

03/19/08 Wound has good granulation base, and epithelium

Current Diagnosis

Ulcer, posterior left heel

beginning to close; wound was gently cleansed

03/26/08 Wound debrided of slough from skin, cleansed, and prepped, 3rd Dermagraft application

04/02/08 Wound has good granulation base; wound cleansed

and prepped, 4th Dermagraft application

04/09/08 Wound is very shallow; no Dermagraft applied 04/16/08 Wound healed

Date: 02/20/08

Date: 03/05/08

Date: 03/12/08

Pre-Debridement Wound Size: 5.6cm x 3.0cm x .3cm

2nd Dermagraft Application Wound Size: 3.2cm x 3.3cm x .4cm

Wound Size: 3.0cm x 2.2cm x .2cm

Date: 03/26/08

Date: 04/09/08

Date: 04/16/08

3rd Dermagraft Application Wound Size: 2.2cm x 2.2cm x .2cm

Wound Size: .5cm x .6cm x .2cm


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Derm a g r a f t R e i mburseme n t H o t l 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.

Derm a g r a f t Cust o mer Ass i st a 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)

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