Evidence map›Paper›PMID 25424146›Full record

Trial reportInternational wound journal2015

A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers.

Charles M Zelen, Lisa Gould, Thomas E Serena, Marissa J Carter, Jennifer Keller, William W Li

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International wound journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03521258 (Limb Salvage Through Tissue Engineering), which is not on this map. Cited by 66 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 6 pooled it
12.2field-weighted citation impact, top 1% 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.

NCT03521258 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane

TypeinterventionalSponsorLouisiana State University Health Sciences Center in New OrleansRan2016 to 2019Enrolled53ConditionsWounds, Trauma, Injury, Limb SalvageArmsDehydrated Human Amnion/Chorion Membrane, Flap-Based Reconstructive Surgery
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 6 syntheses or guidelines pooled it, 176 citations in OpenAlex.

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  7. Fish skin grafts compared to human amnion/chorion membrane allografts: A double-blind, prospective, randomized clinical trial of acute wound healing.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 2020
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6 more citing papers are in PubMed but not listed here.

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

6 authors at 6 institutions in 1 country.

Charles M ZelenProfessional Education and Research Institute, Roanoke, VA, USA.
Lisa GouldWound Recovery Center, Kent Hospital, Warwick, RI, USA.ORCID http://orcid.org/0000-0001-5167-4679
Thomas E SerenaSerena Group, Cambridge, MA, USA.
Marissa J CarterStrategic Solutions, Inc., Cody, WY, USA.
Jennifer KellerShenandoah Lower Extremity Research, Daleville, VA, USA.
William W LiThe Angiogenesis Foundation, Boston, MA, USA.
Angiogenesis Foundation · USGlobal Strategic Solutions (United States) · USKent Hospital · USProfessional Education and Research Institute · USSerenaGroup Research Institute · USShenandoah University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A prospective, randomised, controlled, parallel group, multi-centre clinical trial was conducted at three sites to compare the healing effectiveness of treatment of chronic lower extremity diabetic ulcers with either weekly applications of Apligraf(®) (Organogenesis, Inc., Canton, MA), EpiFix(®) (MiMedx Group, Inc., Marietta, GA), or standard wound care with collagen-alginate dressing. The primary study outcome was the percent change in complete wound healing after 4 and 6 weeks of treatment. Secondary outcomes included percent change in wound area per week, velocity of wound closure and a calculation of the amount and cost of Apligraf or EpiFix used. A total of 65 subjects entered the 2-week run-in period and 60 were randomised (20 per group). The proportion of patients in the EpiFix group achieving complete wound closure within 4 and 6 weeks was 85% and 95%, significantly higher (all adjusted P-values ≤ 0·003) than for patients receiving Apligraf (35% and 45%), or standard care (30% and 35%). After 1 week, wounds treated with EpiFix had reduced in area by 83·5% compared with 53·1% for wounds treated with Apligraf. Median time to healing was significantly faster (all adjusted P-values ≤0·001) with EpiFix (13 days) compared to Apligraf (49 days) or standard care (49 days). The mean number of grafts used and the graft cost per patient were lower in the EpiFix group campared to the Apligraf group, at 2·15 grafts at a cost of $1669 versus 6·2 grafts at a cost of $9216, respectively. The results of this study demonstrate the clinical and resource utilisation superiority of EpiFix compared to Apligraf or standard of care, for the treatment of diabetic ulcers of the lower extremities.

Indexed as

Biological DressingsSkin, ArtificialAgedAmnionChorionCollagenDiabetic FootFemaleHumansMaleMiddle AgedProspective StudiesStandard of CareTreatment OutcomeWound HealingApligrafCollagenAdvanced wound careAmniotic membraneComparative effectivenessCost effectivenessDiabetic ulcers

Identifiers

PMID25424146
PMCPMC7950807
OpenAlexW1572306833

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.