An Open-Label, Interventional, Prospective, Real-World Evidence Study to Evaluate a Multimodal Wound Matrix in Patients with Refractory Wounds
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT Objective The objective of this open-label, interventional, prospective clinical study was to evaluate the effectiveness of a multimodal wound matrix (MWM), formulated for the treatment of chronic, non- healing wounds that had failed prior therapies. The overall response rate was the proportion of patients that had greater than 40% reduction in size after 4 weeks of treatment. Secondary objectives included the percentage area reduction (PAR) after 4 and 12 weeks, incidence of ulcers closing, and changes in quality of life. Approach An open-label, interventional, prospective cohort, real-world evidence study was conducted at 8 US wound care sites. Criteria included chronic non-healing wounds of multiple etiologies in patients with extensive comorbidities. Results were compared to data from the US Wound Registry. Results 111 patients entered the screening phase and 63 were treated. 54 wounds were eligible for the dataset that included 18 DFUs, 19 VLUs, 2 pressure injuries, 1 surgical, 1 lower extremity wound, and 12 unclassified etiologies. The objective response rate was 42%. The 4-week PAR was 34%. The 12-week PAR was 66%. 18 wounds closed by week 12. Innovation MWM is a formulation technology developed to address the major obstacles that prevent healing. Results were evaluated in a patient population with extensive comorbidities who had failed prior treatments and would be generally excluded from controlled trials. Conclusion The results from this study support the contention that the multimodal wound matrix achieves substantial clinical improvement in a complex patient population not enrolled in clinical trials and demonstrates an advancement in wound management.
Source: Advances in Wound Care
Authors: Yadwinder Dhillon, Gerit Mulder, Keyur Patel, Luis Moya, Gerard Boghossian, David Swain, Robert McLafferty, Kelly Perez, Jessica Nguyen, Natalie Wilkinson, Jessica Arragon, Lillia Contreras, Donna Geiger, Ryan Cummings, Brenda LaVigne, Desmond Bell, Suzanne Bakewell
Language: English
Topic: Wound Healing and Treatments
Subfield: Rehabilitation
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4407407525