Increased Healing Rates of Venous Leg Ulcers Treated with Native Type I Collagen Matrix Plus Polyhexamethylene Biguanide (PHMB) Antimicrobial in Addition to Standard Practices: Interim Results from the RESPOND Registry

Objective: Bacterial bioburden and biofilm can result in elevated protease activity which has been associated with prolonging the inflammatory phase, and contribute to the chronicity of venous leg ulcers (VLUs). (Purified) native type 1 collagen matrix, in combination with polyhexamethylene biguanide (PHMB) antimicrobial (PCMP),(*) is believed to manage bacterial bioburden and prevent biofilm reformation.

Purpose: We present an analysis of the effect of PCMP on VLUs in subjects from a prospective registry of patients treated with PCMP on a variety of wounds.

Methods: RESPOND is a prospective registry of 300 patients from 30 centers in the US. Patients, with a variety of wounds, are treated with PCMP in addition to standard practices, followed for 24 weeks. Interim analysis of the first 18 VLU patients of the registry was performed. All patients received venous studies and appropriate endovenous interventions in addition to compression, venous ulcer debridements, and weekly PCMP applications, as indicated.

Results: 18 patients with 18 VLUs (mean age 79.2, 67% Female, BMI 26.7, mean ulcer area 14.95 cm², mean duration 3.92 months prior to study enrollment) were treated. By week 4, a total of 7 VLUs (38.8%) healed and 11 showed greater than 40% reduction in wound area.  By week 8, a total of 12 VLUs (66.6%) showed greater than 80% reduction in wound area. By week 12, 11 VLUs (61.1%) healed completely. Of the remaining 7 VLUs that did not close by week 12, 4 were significantly reduced in size; so, by week 12, 15 VLUs (83.3%) either healed or improved. 

Conclusions: PCMP  with appropriate adjunct local care and  endovenous interventions showed improved VLU healing rates. The success of this VLU strategy demonstrates the importance of managing bioburden/ biofilm reformation. This, in addition to applying an integrated strategy involving endovenous interventions can improve VLU healing and reduce complications.