Diabetic Foot Ulcers Treated With Porcine Urinary Bladder Extracellular Matrix and Total Contact Cast: Interim Analysis of a Randomized, Controlled Trial

Objective. To evaluate the effectiveness of a porcine urinary bladder-derived extracellular matrix (UBM) for the treatment of recalcitrant, neuropathic diabetic foot ulcers (DFUs). Materials and Methods. This prospective, parallel, randomized, single-center study involving 17 subjects was performed in an outpatient wound care center setting. Each subject with a DFU was randomized (2:1) to receive the urinary bladder matrix (UBM) plus offloading with a total contact cast (TCC) or standard care (nonadherent dressing plus TCC). All DFUs were on the plantar surface of the foot and all were Grade I-A according to the University of Texas Wound Classification System. A traditional TCC was used in all patients and consisted of a minimally padded, well-molded, and rigid (plaster plus fiberglass) construct that maintains contact with the entire plantar surface of the foot and lower leg. The endpoints of the study were wound healing at 12 and 16 weeks and ulcer recurrence at 1 year. Wound evaluations were performed weekly and wound surface area was measured by photo-digital planimetry. Results. In the UBM group, the incidence of wound healing at 12 and 16 weeks was 90% and 100%, respectively, compared with 33% and 83.3% in the control (P =.062). The mean time to healing in the UBMtreated group was 62.4 days compared with 92.8 days in the control " group (P=.031). The incidence of ulcer recurrence at 1 year was 10% (1/11) in the UBM-treated group and 50% (3/6) in the control. Conclusion. Results of this interim analysis suggest treatment of DFUs with a UBM could significantly reduce the time to healing and improve the rate of recurrence.