Evidence map›Paper›PMID 39245798›Full record

ArticleInternational wound journal2024

A multicentre clinical trial evaluating the outcomes of two application regimens of a unique keratin-based graft in the treatment of Wagner grade one non-healing diabetic foot ulcers.

David G Armstrong, Dennis P Orgill, Robert D Galiano, Paul M Glat, Marissa J Carter, Jason Hanft, Maria Surprenant, Adam L Isaac, Charles M Zelen

Abstract readMulticenter Study
In one paragraph

Article in International wound journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
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

9 authors.

David G ArmstrongDivision of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Dennis P OrgillProfessional Education and Research Institute (PERI), Roanoke, Virginia, USA.
Robert D GalianoDivision of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Paul M GlatDepartment of Surgery, Drexel University School of Medicine, Philadelphia, Pennsylvania, USA.
Marissa J CarterStrategic Solutions, Inc., Bozeman, Montana, USA.ORCID https://orcid.org/0000-0002-2265-6639
Jason HanftDoctors Research Network, Miami, Florida, USA.
Maria SurprenantDoctors Research Network, Miami, Florida, USA.
Adam L IsaacFoot and Ankle Specialists of the Mid-Atlantic (FASMA), Frederick, Maryland, USA.ORCID https://orcid.org/0000-0001-5338-3445
Charles M ZelenProfessional Education and Research Institute (PERI), Roanoke, Virginia, USA.ORCID https://orcid.org/0000-0001-5682-7056

Funding

ProgenaCare Global
6 · The paper itself

Abstract

Diabetic foot complications that lead to lower extremity amputations pose a significant challenge to the entire global health system. In this multicentre clinical trial, 26 patients with chronic Wagner one diabetic foot ulcers (DFUs) were treated with a unique human keratin matrix graft applied either weekly or bi-weekly, in addition to standard of care. The hypothesis was that bi-weekly application would be similar to weekly application. The primary endpoint was complete wound closure by 12 weeks, and secondary endpoints included healing time, percent area reduction and weekly changes in peripheral neuropathy, pain and quality of life. In the intent-to-treat population, 77% (10/13) of DFUs treated with bi-weekly application healed compared with 69% (9/13) treated with weekly application. The mean time to heal within 12 weeks in the bi-weekly group was 61 days and in the weekly group was 54 days. The mean percent area reduction at 12 weeks was 94.7% in the bi-weekly group compared with 84.8% in the weekly group. The number of grafts used in the bi-weekly group was 3.9 compared with 6.2 in the weekly group. The results of this trial confirm our hypothesis that whether bi-weekly or weekly application of the unique keratin matrix graft is used to treat nonhealing indolent DFUs, there is a high rate of complete healing. Based on these results, future studies should be conducted that further investigate the use of this novel human keratin matrix graft for the treatment of chronic DFUs.

Indexed as

Diabetic FootKeratinsWound HealingAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedTreatment OutcomeKeratinsdiabetic foot ulcerhuman keratin matrix graftwound healing

Identifiers

PMID39245798
PMCPMC11381183

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.