Evidence map›Paper›PMID 27073000›Full record

Trial reportInternational wound journal2017

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.

Charles M Zelen, Dennis P Orgill, Thomas Serena, Robert Galiano, Marissa J Carter, Lawrence A DiDomenico, Jennifer Keller, Jarrod Kaufman, William W Li

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International wound journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 4 pooled it
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 4 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 9 institutions in 1 country.

Charles M ZelenDepartment of Medical Education, Professional Education and Research Institute, Roanoke, VA, USA.
Dennis P OrgillDepartment of Plastic Surgery, Brigham and Women's Hospital, Boston, MA, USA.
Thomas SerenaSerena Group, Cambridge, MA, USA.
Robert GalianoDivision of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Marissa J CarterStrategic Solutions Inc., Cody, WY, USA.
Lawrence A DiDomenicoLower Extremity Institute for Research and Therapy, Youngstown, OH, USA.
Jennifer KellerShenandoah Lower Extremity Research, Troutville, VA, USA.
Jarrod KaufmanGeneral Surgery, Premier Surgical, Brick, NJ, USA.
William W LiThe Angiogenesis Foundation, Cambridge, MA, USA.
Angiogenesis Foundation · USBrigham and Women's Hospital · USGlobal Strategic Solutions (United States) · USNorthwestern University · USPremier Research Group · USProfessional Education and Research Institute · USSerenaGroup Research Institute · USTrout Unlimited · USYoungstown State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acellular 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.

Indexed as

Acellular DermisAdolescentAdultAgedAged, 80 and overChildChronic DiseaseDiabetic FootHumansMaleMiddle AgedProspective StudiesSkin, ArtificialStandard of CareTreatment OutcomeWound HealingDiabetic foot ulcersHuman acellular dermal tissueRandomised controlled trialStandard of care

Identifiers

PMID27073000
PMCPMC7949710
OpenAlexW2337821660

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.