How To Treat Diabetic Ulcers With Dermagraft

Author(s): 
By Patricia L. Abu-Rumman, DPM, Barbara Aung, DPM, and David G. Armstrong, DPM

The prevalence of diabetic ulceration is alarmingly high and increasing. Currently, it is between 4 and 10 percent, depending on a host of factors including ethnicity, geographic region and duration of disease. Wounds are clearly associated with infection and a high risk of future amputation. The economic implications are overwhelming to the health care system. As clinicians, we must be able to rapidly identify, access and manipulate the factors necessary for wound healing.
Indeed, it is vital to approach the wound healing process as a whole body process when you’re treating a patient who has diabetes. You must address and influence the vascular and nutritional status of the patient. We must reduce the microflora of the wound through debridement and appropriate topical or systemic antimicrobials, and offload the ulcerated area to reduce repetitive shear and vertical pressure.
Until the approval of various bioengineered tissues, most recently Dermagraft, we had not been able to influence — on a molecular level — the quality of tissue produced at the wound site in a patient with diabetes. Studies have shown a decreased level of production and an increased level of abnormal collagen in a chronic wound. Diabetic patients have higher levels of collagen glycosylation, which produces abnormal crosslinking.1-3 Crosslinking forms the superstructure that provides the tensile strength to the wound base. This necessary requirement of wound healing must be influenced at the level of the fibroblast, which produces most of the collagen.
Dermagraft is a bioengineered living matrix of cultured neonatal fibroblasts seeded on an absorbable (polyglactin) mesh measuring 2x3 inches (5cm x 7.5cm).4-7 Once it is cultured, the mesh is then frozen and shipped in a cyroprotectant. After the rapid thawing procedure, then you can apply the graft to the wound. The graft provides a living matrix of neonatal fibroblasts that produce collagen, glycosaminoglycans and other proteins for approximately two weeks.
Keep in mind the cell lines used in this human dermal substitute are tested thoroughly for infective agents. They also undergo extensive genetic and antigenic testing. The only contraindications cited at this time are the presence of clinical infection or a hypersensitivity to bovine products.

What The Research Reveals
Researchers have completed several clinical trials. Gentzkow et. al., completed the earliest published study to assess the frequency and dosing requirements for Dermagraft.8 They found that using a tissue graft every week for a total of eight weeks resulted in a 50 percent rate of healing, while conventional care for the same duration resulted in only an 8 percent rate of healing.
Another multi-center clinical pivotal trial applied this dosing regime to a maximum of eight grafts over a 12-week evaluation period.9 The end point of the study was complete closure of the ulceration at 12 weeks and maintained closure at week 16. Closure rate of the Dermagraft group ranged between 22 to 38 percent and the control group ranged between 12 to 26 percent at the 95 percent probability level.9
Using a Markov cost-effectiveness model, Allenet et. al., suggested that using Dermagraft on all patients in a 100 patient cohort, would result in a long-term cost savings of approximately 6 percent.10 You might presume these savings would be even more substantial if the attending physician had discretion as to who might benefit from therapy and who would not.
Dermagraft received FDA approval for treating diabetic foot ulcers late last year.11,12 (See “News And Trends,” November, 2001, pg. 11.) Indications for use include the full thickness diabetic foot ulceration. It is recommended that you do not use Dermagraft over exposed tendon, capsule or bone.
Key Pearls And Insights For Applying Dermagraft Successfully
The procedure for applying Dermagraft often begins the week before you plan to use it. We begin with an aggressive debridement of the wound, as is the standard at our institution. Following this, we will attempt to pragmatically reduce the bacterial burden in the wound. First and foremost, we do this via debridement, but you can also use other modalities. We prefer using a silver-ion donating dressing (Acticoat) or a cadexomer-iodine based topical (Iodosorb).

Comments

Are Dermagraft treatments often used for large , deep wounds? and are they successful?

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