A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix.
Shawn Cazzell, Peter M Moyer, Brian Samsell and 3 others
PMID 31361269WHAT IT FOUND
All 47 per-protocol patients with exposed-bone diabetic foot ulcers reached 100% granulation by 16 weeks, averaging 4 weeks, after debridement, acellular dermal matrix, offloading, dressings, some negative-pressure wound therapy, and infection or osteomyelitis treatment; no control means effects cannot be separated.
Key findings
01All 47 per-protocol participants achieved 100% wound granulation by 16 weeks, and the mean time to granulation was 4.0 weeks.
02The mean wound area reduction was 80.3%, from 29.0 +/- 21.0 cm2 at baseline to 5.7 +/- 8.9 cm2 by week 16.
03Ulcers 15 cm2 or smaller were 14 times more likely to heal than ulcers 29 cm2 or larger (hazard ratio 13.8, P = 0.0008).
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The trial had no control group, so it cannot show whether the acellular dermal matrix, debridement, offloading, dressings, negative-pressure therapy, or infection treatment produced the granulation. Efficacy results were based on 47 per-protocol participants, not all 61 enrolled; 14 did not complete 16 weeks. Granulation was judged by the site investigator, and the study was unblinded. Follow-up stopped at 16 weeks, which was too short for very large ulcers to fully heal. Negative-pressure wound therapy was prescribed at only one site, so its effect cannot be separated from the rest of care. Confidence intervals for the effect of baseline wound size were wide, so the size effect needs confirmation in a larger study. Hemoglobin A1c was recorded for only 16 participants, so glycemic control information is incomplete. One per-protocol participant was nonadherent to offloading, negative-pressure therapy, and dressing changes, and the wound area increased.
The easy way to misread this
Do not read 100% granulation as proof that the acellular dermal matrix caused healing. The trial had no control group, and patients received debridement, acellular dermal matrix, offloading, dressings, possible negative-pressure wound therapy, and infection or osteomyelitis treatment; efficacy was analyzed mainly in 47 of 61 participants who completed 16 weeks.