A Bilayered Living Cellular Construct Accelerates Wound Healing in Diabetic Foot Ulcers

Purpose:  To characterize the rate of diabetic foot ulcer (DFU) healing with a bilayered living cellular construct (BLCC) plus conventional therapy vs. conventional therapy alone (Control). 

Methods:  The safety and effectiveness of BLCC vs. Control were evaluated in 208 patients (N=112 BLCC, N=96 Control) in a randomized, controlled clinical trial.  Patients were eligible to receive up to 5 BLCC applications within the first 4 weeks.  Wound area was calculated from tracings at weekly visits.  Complete wound closure was evaluated through 12 weeks of follow-up.    

Results:  Mean (SD) wound area at baseline was 2.91 (2.81) cm².  At Week 1, BLCC-treated wounds showed a rapid reduction in mean wound area that was significantly greater than that observed with Control (41% vs. 27%; Wilcoxon test, p=0.0004).  Time to complete wound closure through Week 12 was 59% faster for BLCC-treated DFUs compared with Control-treated DFUs (covariate-adjusted Cox proportional hazards model; likelihood ratio p=0.0001). The incidence of adverse events was similar between groups; however, osteomyelitis at the treatment site (2.7% vs. 10.4%) and amputation of the treated limb (6.3% vs. 15.6%) were less frequent with BLCC vs. Control.

Conclusion: The results demonstrate an early acceleration of wound area reduction coinciding with the BLCC application period. A faster time to complete wound closure was observed with BLCC compared with Control. The data suggest that the rate at which a wound can be reduced in size may be further optimized with BLCC through an increased ‘healing momentum’ following application, leading to an accelerated trajectory toward closure.