Standard care noninferior to acellular, cellular matrix products for diabetic foot ulcers
Researchers found no clinically significant differences in ulcer healing between the treatment types but found that acellular matrix products were more cost-effective than cellular matrix products and should thus be considered if standard care fails.
There was no difference in efficacy between standard care, acellular matrix (ACM) products, and cellular matrix (CM) products for nonhealing diabetic foot ulcers, a randomized clinical trial found.
The single-blinded Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE) randomly assigned 117 patients (mean age, 62 years) with a full-thickness nonhealing diabetic foot ulcer to one of the three treatment options between October 2011 and March 2018. Participants, recruited from Veterans Affairs (VA) clinics, received standard of care (n=28), CM (n=41), or ACM (n=48) for 12 weeks, with the primary outcome being the percentage of wounds healed at that time. There were 21 patients who withdrew from the study; of these, seven reached the first primary end point. Findings were published by Diabetes Care on April 29.
Sixty-nine participants (59%) had complete re-epithelialization of the ulcer by 12 weeks. Of these, 20 (49%) were in the CM group, 33 (69%) in the ACM group, and 16 (57%) in the standard care group (P=0.16). Twenty-five participants (61%) in the CM group, 27 (56%) in the ACM group, and 18 (64%) in the standard care group had healed at 28 weeks (P=0.78). Participants with shorter-duration wounds were more likely to heal than patients with longer-duration wounds. No differences were seen in wound recidivism rates or adverse events between the groups. The cost of the CM to the VA system during the study period was $1,081.50 per unit application; the label recommends eight applications. In comparison, the cost of the ACM to the VA system during the study was $107.57 per application, 10-fold lower per application than the CM.
The study is the largest head-to-head, non-industry-sponsored randomized trial comparing the efficacy of CM with ACM for diabetic foot ulcer treatment, the authors wrote. Limitations include that investigators were not blinded to the treatment type and that they were unable to control participants' adherence to offloading. The authors concluded that improving the standard of care would provide the best outcome for patients, but between the matrices, ACM seemed to be the more cost-effective approach.