Cazzell SM, Caporusso J, Vayser D, Davis RD, Alvarez OM, Sabolinski ML, et al.
Journal of wound care. Date of publication 2024 Jul 1;volume 33(Sup7):S4-S14.
1. J Wound Care. 2024 Jul 1;33(Sup7):S4-S14. doi: 10.12968/jowc.2024.0139. Epub
2024 Jun 6.
Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot
ulcers: a randomised controlled trial.
Cazzell SM(1), Caporusso J(2), Vayser D(3), Davis RD(4), Alvarez OM(5),
Sabolinski ML(6).
Author information:
(1)Limb Preservation Platform, Inc., Fresno, CA, US.
(2)Futuro Clinical Trials, McAllen, TX, US.
(3)ILD Research Center, Vista, CA, US.
(4)St. Vincent's Medical Center, Bridgeport, CT, US.
(5)Department of Surgery, Division of Plastic Surgery, Rutgers NJMS, Newark, NJ,
US.
(6)Sabolinski LLC, Franklin, MA, US.
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.
DECLARATION OF INTEREST: This study was funded by Organogenesis Inc., US. JC
serves as a consultant and speaker for Organogenesis. RDD serves as a speaker
for Organogenesis. OMA and MLS serve as consultants for Organogenesis. The
authors have no other conflicts of interest to declare.
DOI: 10.12968/jowc.2024.0139
PMID: 38973638 [Indexed for MEDLINE]
