Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed.
A federally funded trial found clinical equivalence in diabetic foot ulcer (DFU) healing between cellular matrix (CM) and the less costly acellular matrix (ACM) products.
In contrast to findings of industry-sponsored trials, patients who received standard-of-care (SOC) weekly wound care had healing rates equivalent to that of patients treated with either CM or ACM products. Any of the three tested treatment methods can be used; there is no strong evidence that one is clearly better than the other two.
Why This Matters
Nonbiased studies directly comparing ACMs vs the more costly CMs have been lacking because industry rarely sponsors head-to-head trials, whereas other funding agencies prefer to sponsor hypothesis-driven studies over noninferiority studies.
When treating full-thickness Wagner grade 1 DFU, reduced reliance on costly products that do not improve healing compared with less costly products or even SOC can reduce the economic burden of DFU while still providing appropriate conditions for healing.
The cost is approximately $110 per application for ACM products and up to $1800 per application for CM products. An SOC approach avoids both expenses.
A randomized, single-blinded, three-arm, controlled noninferiority trial involving 117 patients with DFU was carried out at several centers of the Veterans Administration (VA) Northern California Health Care System comparing ACM (Oasis) with CM (Dermagraft) and SOC arm for up to eight weekly matrix treatment applications during October 2011 through March 2018. Of the 117 enrolled patients, 103 remained in the study after 12 weeks, the time of the primary efficacy assessment.
SOC included sharp debridement of the wound bed plus wound care including Iodosorb gel.
All participants wore removable walking boots.
Midway through the study, the results showed that wound outcomes using either CM or ACM were similar to outcomes using SOC, so further SOC recruitment stopped, and subsequent enrollment focused on comparing CM with ACM.
Complete wound healing after 12 weeks occurred in 69 enrolled patients (67%) overall, including 20 in the CM group (57% of these patients), 33 in the ACM group (79%), and 16 in the SOC group (62%). The between-group differences among all three subgroups were not significant.
At a second healing assessment at 29 weeks, 96 patients were available for follow-up; overall, the wounds of 70 patients (73%) healed, including 25 of those who received CM (74%), 27 treated with ACM (69%), and 18 managed with SOC (78%). Once again no significant between-group differences appeared in healing rates.
The results also show no significant between-group differences in time to complete wound healing.
Serious adverse events — including soft tissue infection, osteomyelitis, or both — that required hospitalization occurred in two people treated with CM, three who received ACM, and in one patient in the SOC arm.
Costs to the VA system during the study averaged $1081.50 per CM application and $107.57 for each ACM treatment, a roughly 10-fold price difference.
The study's design could not include blind the investigators owing to the distinctive nature of the matrix products tested.
The researchers were unable to control adherence to foot offloading by the study participants.
The results cannot be extrapolating to patients with wound types other than the type enrolled in the study (Wagner grade 1), nor to treatment with matrix products other than the one cellular and one acellular product tested.
The study received no commercial funding.
None of the authors had disclosures.
This is a summary of a preprint research study, "Cellular vs. acellular matrix products for diabetic foot ulcer treatment (DOLCE): A randomized, single-blinded, non-inferiority trial," by researchers primarily at the VA Northern California Health Care System, Mather, California, published on Preprints with The Lancet and provided to you by Medscape. This study has not yet been peer reviewed. The full text of the study can be found on https://www.ssrn.com/index.cfm/en/the-lancet/.