Journal Article Randomized Controlled Trial Multicenter Study Ppublish
PubMed: 42823610 DOI: 10.1111/iwj.71056
A Composite Ovine Forestomach Matrix and Hyaluronic Acid CAMP for the Treatment of Full Thickness Wounds of the Foot in People With Diabetes: A Randomized Controlled Trial.
Int Wound J 23(10):e71056
Authors: David G Armstrong, Dennis P Orgill, Robert D Galiano, John C Lantis, Paul Glat, Alexander M Reyzelman, Robert J Snyder, Adam L Isaac, Marissa J Carter, Charles M Zelen
Affiliations
- Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, California, USA.
- Division of Plastic Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.
- Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
- Department of Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
- Department of Surgery, Drexel University School of Medicine, Philadelphia, Pennsylvania, USA.
- Center for Clinical Research, Castro Valley, California, USA.
- Barry University School of Podiatric Medicine, Miami Shores, Florida, USA.
- Professional Education and Research Institute, Roanoke, Virginia, USA.
- Strategic Solutions, Inc. Cody, Wyoming, USA.
Abstract
Diabetic foot ulcers (DFUs) are a devastating complication of diabetes that markedly affects quality of life and generates significant socioeconomic and healthcare burdens. When DFUs fail to respond to standard of care (SOC), advanced therapies including Cellular, Acellular and Matrix-like Products (CAMPs) are often employed. A novel composite CAMP comprising ovine forestomach matrix and high molecular weight hyaluronic acid, termed 'OFM-HA' has been developed for the treatment of chronic wounds and evaluated in a prospective multi-centre controlled trial. For this trial, 143 subjects were randomized to receive OFM-HA plus SOC or SOC alone for the treatment of chronic full thickness wounds of the foot in people with diabetes meeting prespecified eligibility criteria. The primary endpoint was the proportion of wounds healed by 12 weeks. Secondary endpoints included healing time, percentage area reduction, adverse events and changes in pain and quality of life. For the modified intent-to-treat population, 46% (31/68) of the OFM-HA plus SOC group healed by 12 weeks compared to 24% (17/72) in the SOC alone group (p = 0.008). Kaplan-Meier analysis favoured OFM-HA plus SOC over 12 weeks (log-rank p = 0.023). No unexpected safety-related occurrences were observed. OFM-HA plus SOC increased 12-week closure in this selected population. Interpretation is limited by post-randomization exclusions, differential withdrawal and an adjusted comparison close to the significance threshold (p = 0.045).
MeSH
Diabetes Mellitus, Quality Of Life, Hyaluronic Acid, Foot, Therapeutics, Wounds And Injuries