Evidence map›Paper›PMID 37402533›Full record

Trial reportInternational wound journal2023

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis.

David G Armstrong, Dennis P Orgill, Robert Galiano, Paul M Glat, Lawrence Didomenico, Nikolai A Sopko, Edward W Swanson, Felix Sigal, Robert Snyder, William W Li and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International wound journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07222540 (Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–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.

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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Single-Cell Sequencing Reveals That CCL2+ Adipose-Derived Stem Cells Promote Diabetic Wound Healing Through the CCL2-ACKR1 Signaling Axis.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Article
  5. Review
  6. Review
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

12 authors.

David G ArmstrongDepartment of Surgery, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.ORCID https://orcid.org/0000-0003-1887-9175
Dennis P OrgillDivision of Plastic Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-8279-7310
Robert GalianoDivision of Plastic Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0001-9552-6483
Paul M GlatDrexel University, Philadelphia, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-5009-8603
Lawrence DidomenicoLower Extremity Institute of Research and Therapy, Youngstown, Ohio, USA.
Nikolai A SopkoPolarityTE, Salt Lake City, Utah, USA.
Edward W SwansonPolarityTE, Salt Lake City, Utah, USA.
Felix SigalFoot and Ankle Clinic, Los Angeles, California, USA.
Robert SnyderClinical Research Barry University SPM, Brand Research Center, Barry University, Miami, Florida, USA.
William W LiThe Angiogenesis Foundation, Cambridge, Massachusetts, USA.
Marissa CarterStrategic Solutions, Bozeman, Montana, USA.ORCID https://orcid.org/0000-0002-2265-6639
Charles M ZelenThe Professional Education and Research Institute (PERI), Roanoke, Virginia, USA.ORCID https://orcid.org/0000-0001-5682-7056

Funding

Polarity TE 004
6 · The paper itself

Abstract

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.

Indexed as

Diabetes MellitusDiabetic FootSkin, ArtificialHumansSkinTreatment OutcomeWound Healingbiological productsdiabetic foot ulcerrandomized controlled trialwound healing

Identifiers

PMID37402533
PMCPMC10681466

What OpenQuestion holds

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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.