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The initial approach for the management of patients with diabetic foot ulcers involves cleaning and preparing the wound bed to facilitate wound healing and obtain closure of the wound. Several strategies may be used in order to promote wound healing and achieve wound closure including:

• Debridement - Repeated, sharp debridement (surgical removal of dead or infected tissue from a wound) has been shown to be an effective means for promoting healing of diabetic foot ulcers. Although chemical debriding agents, such as enzymes, may also be sometimes used to remove necrotic (dead) tissue from an ulcer, they should not be used as a substitute for surgical debridment.

• Wound dressings - Wound dressings are used to provide the ulcer with a moist, warm environment in order to promote tissue repair and healing. Examples of materials that are used in formulating wound dressings include:

  • hydrogels (e.g., Aquasorb; Duoderm)
  • hydrocolloids (e.g., Aquacel; Comfeel)
  • foams (e.g., LYOfoam; Spyrosorb)
  • alginates (e.g., AlgiSite; Curasorb)

• Growth factors - Growth factors are substances (proteins) that stimulate cell division and proliferation and, therefore, are thought to play an important role in wound healing. Examples of growth factors that may be used to promote healing in diabetic foot ulcers include:

  • becaplermin (Regranex gel)- human recombinant platelet-derived growth factor that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of neuropathic foot ulcers
  • granulocyte colony-stimulating factor (G-CSF) - currently under investigation as a wound healing agent in diabetic foot ulcers

• Soft-tissue wound coverage - A skin graft is usually necessary to obtain coverage of clean, non-healing diabetic foot ulcers. Examples of skin grafts that may be used for soft-tissue coverage include:

  • autologous skin graft - a graft using the patient's own skin
  • cadaveric skin graft - a skin graft taken from a cadaver
  • bioengineered skin substitutes - closely resemble human skin in structure and function (e.g., Apligraf; Dermagraft)

FDA Early Communication Regarding Safety Review of Regranex

Regranex (becaplermin) is a topical medication that is a recombinant form of human platelet-derived growth factor that was approved by the U.S. Food and Drug Administration (FDA) in December 1997 for the treatment of diabetic foot and leg ulcers that are not healing. In March 2008, the FDA issued an early communication that it is conducting a safety review based on study data suggesting that there may be an increased risk of death from cancer in diabetic patients using Regranex Gel to treat and heal diabetic foot ulcers. A preliminary study completed in 2001 using a health insurance plan database of patients with diabetes with no history of cancer indicated that there was an increase in the number of patients who died as a result of cancer among those patients who were prescribed Regranex Gel three or more times.

Following the report of the study completed in 2001, a second study was done using a health insurance database that included the period from January 1998 through June 2003. This study used the database to identify two groups of patients with similar diagnoses and medication use, one of which used Regranex Gel and one group that did not. The results of this study also showed that deaths from cancer were higher for the group of patients who were prescribed Regranex Gel three or more times compared to those who were not treated with the drug. No single type of cancer was identified but rather deaths from all types of cancer combined were observed.