References
Dehydrated amnion chorion membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial
Abstract
Objective:
Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This prospective, multicentre, randomised controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM) (Organogenesis Inc., US) versus standard of care (SoC) alone in complex DFUs in a challenging patient population.
Method:
Subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated equally to two treatment groups: dACM (plus SoC); or SoC alone. The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan–Meier analysis was used to determine median time to complete wound closure (CWC).
Results:
The cohort comprised 218 patients, and these were split equally between the two treatment groups with 109 patients in each. A Cox analysis showed that the estimated frequency of wound closure for the dACM plus SoC group was statistically superior to the SoC alone group at week 4 (12% versus 8%), week 6 (22% versus 11%), week 8 (31% versus 21%), week 10 (42% versus 27%) and week 12 (50% versus 35%), respectively (p=0.04). The computed hazard ratio (1.48 (confidence interval: 0.95, 2.29) showed a 48% greater probability of wound closure in favour of the dACM group. Median time to wound closure for dACM-treated ulcers was 84 days compared to ‘not achieved’ in the SoC-treated group (i.e., ≥50% of SoC-treated DFUs failed to heal by week 12; p=0.04).
Conclusion:
In an adequately powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared with SoC alone. dACM demonstrated beneficial effects in DFUs in a complex patient population.
Prevalence of diabetes in the US has continually increased over the past two decades, peaking at 11.6% of the population in 2021.1 There are an estimated 37.3 million individuals with diabetes in the US, 28.7 million of whom have a confirmed diagnosis.2,3,4 The presence of diabetes carries increased risk for development of lower extremity ulcers, primarily through development of peripheral neuropathy and ischaemia from peripheral vascular disease.5,6 Minor injuries to the skin may go unnoticed and develop into a diabetic foot ulcer (DFU). Patients with diabetes are estimated to carry a 25% lifetime risk of developing a DFU.4 In the US, the estimated overall incidence of DFUs ranges from 6–13% of patients with diabetes, with >1 million having a hard-to-heal DFU (an ulcer persisting for >6 weeks).7,8,9 Among patients with diabetes, >50% of DFUs have been reported to remain unhealed after 12 months. These patients carry a 40% risk of infection for every six months that their wounds remain unhealed.8,10,11 In the worst case, this may lead to lower limb amputation. Approximately 28 out of every 10,000 patients with diabetes will undergo amputation, with up to 85% of all non-traumatic amputations being attributable to DFUs.12,13 In the event of amputation, the 5-year mortality risk is higher than that of many common forms of cancer.14,15,16
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