Clinical Trial of Multiple Wound Etiologies treated with a Multimodal Wound Matrix in a Patient Population Representative of Wound Care Settings in USA.

Introduction: An open-label, interventional clinical trial was conducted at 8 US sites to evaluate a marine-based technology for the treatment of recalcitrant wounds of varying etiologies in a patient population with extensive co-morbidities. Minimal exclusion criteria were used to include patients with profiles typical of those treated in outpatient wound care settings. Patients were treated with a multimodal wound matrix (MWM), applied weekly to chronic ulcers and wound progress was recorded after 4 and 12 weeks of treatment, along with changes in quality of life, pain levels, and adjusted daily lifestyle.Methods:Demographics, comorbidities, medications, and wound history of patients were collected. Previous treatments prior to the trial included All patients underwent a 2-week screening phase, treated with only standard of care (SOC) to confirm that wounds were non-responsive. If wounds did not decrease more than 30% in size, patients moved into the treatment phase and received 4 weekly treatments of MWM. At that time PI’s had the option to continue treatment with MWM through treatment visit (TV) 12. PAR was collected at TV5 and end of study visit or TV12.Results:111 patients were enrolled and 64 were treated with the MWM at 8 different wound care settings. The patient population had an average age of 65 years, ranging from 36-100 years.  BMIs ranged from 16 to 53 with an average of 33. Wound size ranged from 1.31-63.21cm2 (mean 10.6, Median 4.6). The percent area reduction (PAR) after four-weeks of treatment across all etiologies was 32.4% and 68.3% by TV12. 36% of patients saw 100% closure by TV12 and 52% had a PAR greater than 40% at week 12.Discussion: Patients’ prior failed treatments included placental tissues, collagen matrices, antimicrobial dressings, silver alginates, and NPWT among others. This population not only presented with wounds that had not shown indications of healing, but would unlikely qualify for randomized controlled trials, due to their wound status and extensive comorbidities. Results demonstrate MWM’s effect on wounds seen in typical wound care settings in the US. MWM will continue to be assessed in randomized and controlled clinical trials alongside trials with minimal patient restrictions.References: