Bioengineered Skin Substitute

FDA-approved Dermagraft helps achieve rapid closure of lower-extremity ulcers.

DERMATOLOGY When my mother had a foot ulcer, I recall regular visits to the wound-care specialist. He would clean and dress the ulcer in an effort to accelerate healing. For the most part, it appeared he was monitoring progress until the body's own regenerative capabilities repaired the wound. But sometimes, help beyond the body's natural healing abilities is required.

Going beyond pro-ionic hydrogels, over 50,000 patients have been treated with Dermagraft®, which works as a bio-delivery scaffold, delivering "physiologically relevant amounts of proteins, growth factors and matrix to a wound that is having trouble creating those and can significantly assist in the rapid closure of ulcers," says Jason R. Hanft, D.P.M., F.A.C.F.A.S., of the Foot & Ankle Institute, South Miami, Florida (consultant for Advanced BioHealing responsible for Dermagraft clinical trial). [1]

Cultured from human foreskin tissue, Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of fibroblasts, extracellular matrix and a bioabsorbable scaffold. It functions as synthetic connective tissue to promote rapid healing. Connective tissue is a type of tissue made up of fibers forming a framework and support structure for body tissues and organs. [2]

Promising Clinical Research

Researchers have completed several clinical trials. Gentzkow et al., completed the earliest published study to assess the frequency and dosing requirements for Dermagraft. [3] 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. [4,5]

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. [6] 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.

Already approved by FDA for treating diabetic foot ulcers and available for more than 10 years, Dermagraft seeks to expand its therapeutic indications to include the rapid closing of venous leg ulcers through an international, multi-center, prospective, controlled clinical study of 400+ patients.

Dermagraft should not be used on infected ulcers or ulcers with sinus tracts (tunneling). It should not be used on patients allergic to products derived from cows because there is bovine serum in the packaging solution.

Have you used Dermagraft for foot ulcers? What benefits do you see to expanding FDA approval to venous leg ulcers?

Tags: dermatologic, dermatology, diabetes, endocrinology, metabolic

  1. Skin substitute presents therapeutic option for venous leg ulcers. ModernMedicine
  2. What is Connective Tissue?
  3. Gentzkow GD, Iwasaki SD, Hershon KS. Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers. Diabetes Care. 1996; 19:350-354
  4. How To Treat Diabetic Ulcers With Dermagraft. Podiatry Today
  5. Dermagraft Case Studies.
  6. Allenet B, Paree F, Lebrun T, et al. Cost-effectiveness modeling of Dermagraft for the treatment of diabetic foot ulcers in the French context.