A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers

Abstract

A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers AbstractAcellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open-structure human reticular acellular dermis matrix (HR-ADM) to facilitate wound closure in non-healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2-week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR-ADM plus SOC applied weekly for up to 12 weeks. At 6 weeks, the primary outcome time, 65% of the HR-ADM-treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At 12 weeks, the proportions of DFUs healed were 80% and 20%, respectively. Mean time to heal within 12 weeks was 40 days for the HR-ADM group compared with 77 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any adverse events related to the graft. Mean and median graft costs to closure per healed wound in the HR-ADM group were $1475 and $963, respectively. Weekly application of HR-ADM is an effective intervention for promoting closure of non-healing DFUs.

Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi‐centre clinical trial in 80 patients

“…After adjustment for initial wound area, wounds treated with dHACA and SOC were more than 4 times as likely to heal within 12 weeks as wounds treated with SOC alone. Mean and median time to heal for the dHACA group within 12 weeks (37/35 days) was faster than the majority of other cellular and/or tissue‐based products (CTPs) studied in other RCTs, indicating that it may be 1 of the most effective CTPs available.…”

Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial

“…18–24,35 The availability of smaller sizes of dHACA led to lower graft costs and wastage at both 6 and 12 weeks when compared with previously published RCTs that studied soft-tissue grafts as a therapy for diabetic wounds. 23,24 The mean graft cost to wound closure at 12 weeks in all dHACA-healed wounds was $1400, which is among the lowest graft cost to closure reported for any published allograft study.…”

Update on management of diabetic foot ulcers

“…58 Since that publication, Zelen et al published similar findings. 59,60 Campitiello et al published data on an acellular flowable matrix that has a liquid composition that can fill deep cavities and tunneled wounds. They found that healing rates were higher at 6 weeks when compared with usual care with wet dressing.…”