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Cell Therapy Improves Foot Ulcer Healing by 31-40%

Posted: Sunday, August 29, 2010

Engineered skin significantly improved healing of diabetic foot ulcers compared with other advanced biologic therapies, according to an analysis of a larger wound care database.

When used as the initial advanced biologic therapy, engineered skin -- or bilayered living cell therapy (Apligraf) -- reduced the time to wound healing by 31% compared with topical recombinant growth factor (becaplermin, Regranex) and by 40% compared with platelet releasate (Procuren).

The data also showed that earlier initiation of advanced biologic therapy increased the chances of early healing. However, the most effective therapy often was delayed well beyond the recommended 28 days.

Robert S. Kirsner, MD, PhD, of the University of Miami, FL, and co-authors wrote that, "Overall, we found that treatment with advanced biological therapy for non-healing wounds occurred by day 28, consistent with the Wound Healing Society guidelines… However, the median time to use of bilayered living cell therapy was six weeks, compared with four weeks for platelet releasate and three weeks for recombinant growth factor therapy. Furthermore, 25% of wounds treated with bilayered living cell therapy were not treated until after 24 weeks."

The reason for the delay is unclear but could involve the higher cost of engineered skin, they added.

As many as 15% of diabetic patients develop foot ulcers, which are a leading cause of nontraumatic amputation in the U.S. Beyond the associated morbidity, amputation involves direct costs ranging as high as $60,000, the authors noted.

Improved and more rapid healing of diabetic foot ulcers reduces the risk of amputation. Several randomized clinical trials have shown that using advanced biologic therapy in combination with standard treatment (off-loading, debridement, and restoration of skin perfusion) improves healing of diabetic foot ulcers compared with standard therapy alone, the authors continued.

To assess current practices regarding using of advanced biologic therapies, investigators queried the Curative Health Services database, a validated repository for data related to wound care. They identified 2,517 patients with diabetic foot ulcers, all treated with advanced biologic therapy:

    * 1,892 patients treated with recombinant growth factor therapy
    * 446 treated with bilayered living cell therapy
    * 125 treated with platelet releasate
    * 54 treated with bilayered living cell therapy after initial treatment with one of the other advanced therapies

Overall, the time from first visit to initiation of treatment with advanced biologic therapy averaged 28 days including 25% of patients who started therapy by day eight. Three-fourths of patients had received advanced biologic therapy by day 60.

Time to treatment averaged 23 days with becaplermin, 28 days with platelet releasate, and 43 days with bilayered living cell therapy (P<0.001). Patients treated with becaplermin had significantly smaller median wound area (141 mm2), compared with 311 mm2 for bilayered living cell therapy, 329 mm2 for platelet releasate, and 367 mm2 for combination advanced biologic therapy (P<0.001). Patients treated with platelet releasate or more than one advanced biologic therapy had deeper wounds, 3 mm versus 2 mm for the other groups (P<0.001).

Longer time to healing after initial use of advanced biologic therapy was associated with larger wound area (P<0.001), more severe wound grade (P<0.001), longer duration prior to first visit (P=0.003), and longer time from first visit to use of advanced biologic therapy (P=0.001).

The median time from first use of advanced biologic therapy to healing or last observation was 100 days. In a fully adjusted analysis, time to healing was significantly shorter with bilayered living cell therapy (84 days) compared with 100 days for becaplermin (P<0.001), 133 days for platelet releasate (P=0.01), and 175 days for use of bilayered living cell therapy after another advanced biologic therapy (P<0.001).

Acknowledging cost as a factor in the delay in using engineered skin, the authors noted that, "Several studies have found that use of advanced biological therapies, in fact, does reduce costs."

The authors cited several potential limitations of the study: its retrospective nature, lack of data on potential confounding factors, uncertainty about the rigorous nature of data collection, limited review of data quality, and potential confounding by the relationship between healing status and choice of therapy.

Practice Pearls:

* Explain to interested patients that engineered skin significantly improved healing of diabetic foot ulcers compared with other advanced biologic therapies.

* Note that the study was a retrospective review of a database of 2,517 patients with diabetic foot ulcers.

Source: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9737&catid=53&Itemid=8, Kirsner RS, et al "Advanced biological therapies for diabetic foot ulcers" Arch Dermatol 2010; 146: 857-862.