A Pilot Study of Lower Extremity Wounds Utilizing A Novel Synthetic Self-Assembling Peptide Matrix

Introduction: Lower extremity wounds in the United States pose an economic and challenging aspect of post-acute care in populations that undergo Mohs surgical resections and have adverse outcomes that result in open, non-healing sites.  The added cost of these cases for the post-operative failure contributes to the overall financial responsibility of the treating dermatological surgeon and adds comorbidity to these patient populations that already have immunocompromised integument systems.  The challenge with most of these patients is based on wound location, wound bed physiology and abnormal healing pathways that have derailed the normal healing cascade.  This pilot study utilized a nanoparticle Self-Assembling Peptide Matrix (SAPM) as a primary treatment pathway for initiating wound closure.Methods:12 patients were enrolled at a single-site center and treated by the author.  All patients underwent a full history and physical examination with ABI assessment.  Patients enrolled had a minimum of 4 weeks of non-progressive healing post-Mohs surgery.  Average patient age was 80.  The average initial wound size was 4.0 cm2 (range 2.1 cm2 to 8.2 cm2).   All wounds were cleansed with normal saline followed with sharp surgical debridement. Digital photography and wound measurements were obtained. The SAPM was applied per manufacturer instructions, covered with a non-adherent contact layer, polyurethane foam, stretch bandage and secured with a self-adherent wrap.   All wounds were re-assessed weekly at the clinic and treatment was re-applied by the author as necessary.Results:All patients achieved wound closure by week 10.  Average number of applications across all 12 patients was 4.4 applications.  The 4-week reduction of surface area  on average was 2.0 cm2, reflecting a 50% PAR.  Average time to close was 6.9 weeks (range 5-10).  All but 2 of the wounds closed by week 8.  There were no adverse reactions of the SAPM during the clinical study and no recurrences within 6 weeks of closure. Discussion: The failure of grafting post-Moh’s is very rare and infrequent.   Less than 2% of all cases arise to a level of complication necessitating advanced wound closure.  The costs involved with standard of care for a lower extremity wound that is non-progressive is approximately $14,152 over 13 weeks.  Although the use of a SAPM in these cases has a higher cost,  the pilot data showed when aggregated versus the standard of care, the cost-savings is in utilizing the advanced technology. The use of SAPM showed a significant increase in healing time with a more rapid return to normal life.References:1. Margolis D.J., Malay D.S., Hoffstad O.J, et al. Prevalence of diabetes, diabetic foot ulcer, and lower extremity amputation among Medicare beneficiaries, 2006 to 2008: Data Points #1. 2011 Feb 17. In: Data Points Publication Series [Internet]. 2. Agency for Healthcare Research and Quality (US), Rockville, MD2011 3. Nussbaum SR, Carter MJ, Fife CE, DaVanzo J, Haught R, Nusgart M, Cartwright D. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018 Jan;21(1):27-32. doi: 10.1016/j.jval.2017.07.007. Epub 2017 Sep 19. PMID: 29304937. 4. Lantis Ii JC, Lullove EJ, Liden B, McEneaney P, Raphael A, Klein R, Winters C, Huynh RN. Final efficacy and cost analysis of a fish skin graft vs standard of care in the management of chronic diabetic foot ulcers: a prospective, multicenter, randomized controlled clinical trial. Wounds. 2023 Apr;35(4):71-79. doi: 10.25270/wnds/22094. PMID: 37023475.