Evidence map›Paper›PMID 32453512›Full record

Trial reportInternational wound journal2020

Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers.

David G Armstrong, Dennis P Orgill, Robert Galiano, Paul M Glat, Marissa Carter, Charles M Zelen, William W Li

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in International wound journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

NCT03881254 nacompletednot on this map

A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE™ in the Treatment of Wagner One Diabetic Foot Ulcers

TypeinterventionalSponsorPolarityTERan2019 to 2021Enrolled100ConditionsDiabetic Foot, Diabetic Foot Ulcer, Ulcer FootArmsHuman Autologous Homologous Skin Construct, Additional Outer Dressing Applicaiton, Offloading, Fibracol Wound Dressing
NCT07222540 temporarily not availablenot on this map

Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers

Typeexpanded_accessSponsorPolarityTEConditionsDFU, Neuropathic Diabetic Ulcer - Foot, Diabetic Foot DiseaseArmsSkinTE
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 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

7 authors at 7 institutions in 1 country.

David G ArmstrongKeck School of Medicine, University of Southern California, California, Los Angeles, USA.
Dennis P OrgillBrigham and Women's Hospital, Boston, Massachusetts, USA.
Robert GalianoNorthwestern University School of Medicine, Chicago, Illinois, USA.
Paul M GlatDrexel University, Philadelphia, Pennsylvania, USA.
Marissa CarterStrategic Solutions, Inc., Cody, Wyoming, USA.
Charles M ZelenThe Professional Education and Research Institute (PERI), Roanoke, Virginia, USA.ORCID https://orcid.org/0000-0001-5682-7056
William W LiThe Angiogenesis Foundation, Cambridge, Massachusetts, USA.
Angiogenesis Foundation · USBrigham and Women's Hospital · USDrexel University · USGlobal Strategic Solutions (United States) · USNorthwestern University · USProfessional Education and Research Institute · USUniversity of Southern California · US

Funding

Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
NCATS NIH HHS UL1 TR001855PolarityTE Grant001
6 · The paper itself

Abstract

Diabetic foot ulcers (DFUs) are a growing burden on patients and health care systems that often require multiple treatments of both conventional and advanced modalities to achieve complete wound closure. A novel autologous homologous skin construct (AHSC) has been developed to treat cutaneous defects with a single topical application, by leveraging the endogenous repair capabilities of the patient's healthy skin. The AHSC's ability to close DFUs with a single treatment was evaluated in an open-label, single-arm feasibility study. Eleven patients with DFUs extending up to tendon, bone, or capsule received a single topical application of AHSC. Closure was documented weekly with high-resolution digital photography and wound planimetry. All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time-to-complete closure was 25 days. The mean percent area reduction for all 11 wounds at 4 weeks was 83%. There were no adverse events related to the AHSC treatment site. This pilot study demonstrated AHSC may be a viable single application topical intervention for DFUs and warrants investigation in larger, controlled studies.

Indexed as

Diabetes MellitusDiabetic FootFeasibility StudiesHumansPilot ProjectsProspective StudiesWound Healingautologous homologous skin constructdiabetic foot ulcernovel therapywound healing

Identifiers

PMID32453512
PMCPMC7540349
OpenAlexW3032090610

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.