Clinical outcomes of lyophilised human amnion/chorion membrane in treatment of hard-to-heal diabetic foot ulcers in complex cases: a case series

Objective: Diabetic foot ulcers (DFUs) are a common and severe complication of diabetes, characterised by high morbidity, recurrence and risk of amputation. Hard-to-heal (chronic) DFUs often fail to respond to standard of care (SoC), necessitating advanced interventions. Lyophilised human amnion/chorion membrane (LHACM) is a trilayer placental allograft that provides extracellular matrix support, growth factors and anti-inflammatory properties to promote wound closure. This case series evaluates the effectiveness of LHACM as an adjunct to SoC in treating hard-to-heal DFUs unresponsive to conventional treatments. Method: Patients with Wagner Grade 2 or 3 DFUs (each of which had been hard-to-heal and unresponsive to SoC for 1-3 years) and multiple comorbidities were treated with LHACM following thorough wound debridement, customised dressings and offloading strategies. Wound closure, infection control and functional outcomes were assessed. Results: This was a case series of three male patients, aged 65-66 years. All wounds demonstrated significant size reduction within three weeks of treatment, achieving complete closure within a mean of 47 days (range: 35-56 days). No infection recurrences or complications were observed and patients resumed daily activities. LHACM's ease of application and compatibility with SoC facilitated integration into the treatment protocol. Conclusion: LHACM demonstrated effectiveness in accelerating wound closure in complex hard-to-heal DFUs resistant to SoC, highlighting its potential to mitigate complications, reduce healthcare costs and improve patient quality of life. Further large scale studies are warranted to confirm these findings and explore broader applications in advanced wound care. Declaration of interest: This study was sponsored by MIMEDX Group Inc., Marietta, GA, US. MO and DK serve on a MIMEDX speakers bureau. MO serves as a consultant to MIMEDX Group Inc. TG has no conflicts of interest to declare. SS, CD and RAF are employees of MIMEDX.