A Randomized, Investigator-Blinded, Controlled Pilot Study to Evaluate the Safety and Efficacy of a Poly-N-acetyl Glucosamine-derived Membrane Material in Patients with Venous Leg Ulcers

Significance: While no one specific cellular dysfunction has been isolated as the primary pathological feature associated with chronic venous leg ulcers (VLUs), new discoveries in the treatment of wounds in mouse models have lead to the development of a novel treatment technology.

Purpose: To study the efficacy, safety, and tolerability of an advanced, poly-N-acetyl glucosamine, nanofiber-derived, wound healing technology ("pGlcNAc") among patients with VLUs.

Method: A randomized, investigator-blinded, controlled trial was conducted at three outpatient wound clinic sites. A total of 82 patients were randomized to treatment with standard care (wound cleansing, non-adherent dressing, multi-layer compression, leg elevation, calf exercises) plus pGlcNAc applied to the ulcer once only, every other week, or every 3 weeks, or to standard care alone. The primary outcome was the proportion of patients with complete wound healing at week 20 in the intent-to-treat population (all randomized subjects), with last observation carried forward (LOCF).

Statistics: Comparisons between treatment groups for baseline demographic, illness, and ulcer characteristics were performed using chi-square tests or t-tests. Group differences in achieving the primary endpoint (complete wound healing) were examined by chi-square tests.

Results: A total of 71 participants completed the study. There were no significant group differences with regard to baseline demographic, illness, and ulcer characteristics. At 20 weeks, the proportion of patients with completely healed VLUs was 45.0% (n=9/20) for standard care plus pGlcNAc once only, 86.4% (n=19/22) every other week, and 65.0% (n=13/20) every 3 weeks versus 45.0% (n=9/20) for those receiving standard care alone (p<.01 for pGlcNAc every other week versus standard care). There were no side effects associated with pGlcNAc.

Conclusion: The pilot findings suggest that the pGlcNAc advanced wound healing technology is safe, well-tolerated, and effective. Limitations were small sample size and patients unblinded to treatment allocation.