foot-with-ulcerTreating Your Diabetic Foot Ulcer

What is Dermagraft?

Dermagraft is a “skin substitute” that is placed on your ulcer to cover it and to help it heal. It is manufactured in an aseptic environment. It also contains a temporary mesh fabric that will eventually dissolve and go away by itself. Dermagraft is used to treat foot ulcers that have been present for at least 6 weeks in patients with diabetes. It is used together with standard methods of treating DFUs, including cleaning and preparing the ulcer, applying cover dressings to hold it in place, and wearing special shoes to take the pressure off the ulcer (called “off-loading”).

Talking to Your Doctor

Knowing what kinds of questions to ask your physician can be an important first step in helping to manage your diabetic foot ulcer (DFU).

What are the treatment options for a DFU?
How long will it take for my DFU to heal?
What are the possible complications of a DFU?
Should I see a wound care specialist?
For a printable version (PDF) of these questions, click here

What if my wound isn’t healing?

When a wound hasn’t healed in an appropriate amount of time, it may become chronic. When this happens the skin and tissue at the site of the ulcer are often to blame. Damaged or dysfunctional cells and a lack of blood flow can make it hard for the wound to heal itself.10,11
 

THIS IS WHERE DERMAGRAFT COMES IN

Made from human cells known as fibroblasts, grown on temporary mesh, Dermagraft is placed on the ulcer. The living cells in Dermagraft produce many of the same proteins and growth factors found in healthy skin. Dermagraft helps to restore the compromised wound bed to facilitate healing by providing a scaffold where the patient’s own cells can migrate to close the wound. Because the mesh material found in Dermagraft dissolves and becomes part of the body’s own healing processes, you can apply Dermagraft weekly (up to eight times) over a twelve-week period without having to remove the product from the wound.1

Success with Dermagraft

Over 90,000 patients have received Dermagraft since 2007.12 This treatment has been proven safe and effective in a large, randomized clinical trial and is FDA approved for treatment of DFUs.1,2 Hear the real stories of patients who have tried Dermagraft.

In a clinical trial, patients with non-healing DFUs (longer than six weeks) were split into two groups. One group was treated with standard therapies (debridement, wound dressing, and/or off-loading) plus Dermagraft, while the other group was treated with only the standard therapies. Results of the clinical study showed that significantly more patients achieved complete wound closure by 12 weeks when Dermagraft was added to their treatment plan.1,2

Why has my healthcare provider prescribed Dermagraft?

Your healthcare provider has chosen Dermagraft specifically for you because your DFU has not healed. Dermagraft has been shown to heal DFUs in significantly more patients than standard treatment alone.1,2 A DFU can be a serious problem if not properly treated and healed.

What common adverse events have occurred in patients treated with Dermagraft?

In a study of patients with DFUs treated with Dermagraft, the most common adverse events included:

  • infection
  • accidental injury
  • skin blister
  • flu syndrome (e.g., fever, chills, flushing)
  • need for additional surgery involving the DFU
  • occurrence or worsening of other DFUs
  • peripheral edema (swelling of the extremities)

Please contact your healthcare provider if you have any concerns while being treated with Dermagraft.

Who should not receive Dermagraft?

Dermagraft should not be used on foot ulcers that have signs of clinical infection, sinus tracts (narrow passages extending from the wound), or exposed tendon, muscle, joint capsule, or bone.

Dermagraft should not be used in patients with known allergy to bovine (cow) products, as it may contain small amounts of bovine proteins from the manufacturing and storage solutions.

What should I expect before receiving Dermagraft?

Before treating your DFU, your healthcare provider may perform a physical examination and explain the types of tests and treatments you will be receiving. You may also receive an X-ray to make sure that the bones in your feet are not infected. A tissue sample may be collected from the ulcer and tested for the presence of bacteria in order to determine if an antibiotic is necessary before treatment with Dermagraft.

Applying Dermagraft

What will happen during my clinic visits?

Your healthcare provider will apply Dermagraft to your DFU on a regular schedule, typically once a week. The duration of treatment varies, but Dermagraft may be applied on your ulcer weekly for up to 8 applications over 12 weeks. It is very important that you keep each of your scheduled appointments to ensure that your healthcare provider can monitor your progress.

Your healthcare provider will explain that Dermagraft should not cause pain or irritation when in place. However, debridement—the removal of diseased and dead tissue from the ulcer site—can cause some discomfort.

Your healthcare provider will perform a short series of steps at each visit:

  1. Your healthcare provider may debride the ulcer and then clean it with a sterile saline solution. This is to make sure there is a clean surface for application of Dermagraft.
  2. Dermagraft will be thawed, rinsed, and cut to the size of your ulcer.
  3. Dermagraft will be placed on your ulcer and covered with another dressing to keep it clean and protected.
  4. Once Dermagraft and the protective dressing are in place, you will be instructed on how to care for your ulcer, including how to change the dressings when appropriate, and how to keep pressure off your ulcer to help it heal.

Applying-Dermagraft