Evidence map›Paper›PMID 23742102›Full record

Trial reportInternational wound journal2013

A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers.

Charles M Zelen, Thomas E Serena, Guilhem Denoziere, Donald E Fetterolf

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

Trial report in International wound journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03754218 (Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing), which is not on this map. Cited by 106 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 10 pooled it
19.9field-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.

NCT03754218 early_phase1completednot on this mapstarted 2019, after this paper: background citation

Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing

TypeinterventionalSponsorWake Forest University Health SciencesRan2019 to 2023Enrolled7ConditionsBurns, Wound of Skin, Skin WoundArmsAmnion Membrane Powder, SOC Wound Covering
3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 10 syntheses or guidelines pooled it, 261 citations in OpenAlex.

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46 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

4 authors at 3 institutions in 1 country.

Charles M ZelenDepartment of Clinical Research, Professional Education and Research Institute, Inc., Roanoke, VA, USA.
Thomas E Serena
Guilhem Denoziere
Donald E Fetterolf
Kennesaw State University · USProfessional Education and Research Institute · USSerenaGroup Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx, Kennesaw, GA) versus standard of care. An IRB-approved, prospective, randomised, single-centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomised to receive standard care alone or standard care with the addition of EpiFix. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. In the standard care group (n = 12) and the EpiFix group (n = 13) wounds reduced in size by a mean of 32.0% ± 47.3% versus 97.1% ± 7.0% (P < 0.001) after 4 weeks, whereas at 6 weeks wounds were reduced by -1.8% ± 70.3% versus 98.4% ± 5.8% (P < 0.001), standard care versus EpiFix, respectively. After 4 and 6 weeks of treatment the overall healing rate with application of EpiFix was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds (P < 0.001), respectively. Patients treated with EpiFix achieved superior healing rates over standard treatment alone. These results show that using EpiFix in addition to standard care is efficacious for wound healing.

Indexed as

Biological DressingsWound HealingAdultAgedAged, 80 and overAmnionDiabetic FootFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAllograftAmniotic membraneDiabetic ulcerRandomised controlled trialWound healing

Identifiers

PMID23742102
PMCPMC4232235
OpenAlexW2137487929

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.