Evidence map›Paper›PMID 27489115›Full record

Trial reportInternational wound journal2017

A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane.

Robert G Frykberg, Gary W Gibbons, Jodi L Walters, Dane K Wukich, Farrell C Milstein

Registry-linked trialAbstract readClinical TrialMulticenter Study
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. It is linked to trial NCT03685955 (The Effect of Amniotic Membranes on Complex Genitourinary Reconstruction Outcomes in Pediatric and Adult Populations), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
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.

NCT03685955 withdrawnnot on this mapstarted 2020, after this paper: background citation

The Effect of Amniotic Membranes on Complex Genitourinary Reconstruction Outcomes in Pediatric and Adult Populations

Typeobservational_patient_registrySponsorJohns Hopkins UniversityRan2020 to 2021Enrolled0ConditionsHypospadias, Hypospadias and Epispadias and Other Penile Anomalies, Fistula, Fistula, UrinaryArmsAmniotic membranes
3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

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  18. Placental Membranes for Management of Refractory Cutaneous Sinus Tracts of Surgical Origin: A Pilot Study.The journal of the American College of Clinical Wound Specialists · 2016
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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

5 authors.

Robert G FrykbergDepartment of Podiatry, Carl T. Hayden VA Medical Center, Phoenix, AZ, USA.
Gary W GibbonsCenter for Wound Healing, South Shore Hospital, Weymouth, MA, USA.
Jodi L WaltersDepartment of Podiatry, Southern Arizona VA Health Care System, Tucson, AZ, USA.
Dane K WukichUPMC Wound Healing Services, UPMC Mercy, Pittsburgh, PA, USA.
Farrell C MilsteinOsiris Therapeutics, Inc, Columbia, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Complex diabetic foot ulcers (DFUs) with exposed tendon or bone remain a challenge. They are more susceptible to complications such as infection and amputation and require treatments that promote rapid development of granulation tissue and, ultimately, reepithelialisation. The clinical effectiveness of viable cryopreserved human placental membrane (vCHPM) for DFUs has been established in a level 1 trial. However, complex wounds with exposed deeper structures are typically excluded from randomised controlled clinical trials despite being common in clinical practice. We report the results of a prospective, multicentre, open-label, single-arm clinical trial to establish clinical outcomes when vCHPM is applied weekly to complex DFUs with exposed deep structures. Patients with type 1 or type 2 diabetes and a complex DFU extending through the dermis with evidence of exposed muscle, tendon, fascia, bone and/or joint capsule were eligible for inclusion. Of the 31 patients enrolled, 27 completed the study. The mean wound area was 14·6 cm

Indexed as

AgedDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic FootFemaleHumansMaleMiddle AgedPlacentaPregnancyProspective StudiesTransplantsUnited StatesWound HealingChronicComplex woundCryopreserved placental membraneDiabetesUlcer

Identifiers

PMID27489115
PMCPMC7950156

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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.