Evidence map›Paper›PMID 31436621›Full record

Trial reportAdvances in skin & wound care2019

Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial.

Warren Gude, Daniel Hagan, Ferial Abood, Peter Clausen

Abstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in skin & wound care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 6 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.

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

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

  1. Pooled it
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  7. Trial
  8. Review
  9. Article
  10. Platelet-Rich Plasma for Diabetic Foot Ulcers: A Cross-Sectional Appraisal of Overlapping Meta-Analyses.Diabetes, metabolic syndrome and obesity : targets and therapy · 2026
    Article
  11. Review
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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

4 authors.

Warren GudeWarren Gude, MD, is Medical Director, St Luke's Wound and Hyperbaric Clinic; Medical Director, Wound Care at Vibra Hospital; and Medical Director of Wound Care, Meadow View Nursing and Rehabilitation Center, Boise, Idaho. Daniel Hagan, DPM, DABPS, is a podiatrist, Onslow Memorial Hospital Wound Care; and in private practice, Family Foot Care, Jacksonville, North Carolina. Ferial Abood, MD, is Medical Director of Internal Medicine, Advanced Wound Care of South Central New Mexico, Gerald Champion Hospital, Alamogordo, New Mexico. Peter Clausen, PhD, is Chief Science Officer, Nuo Therapeutics Inc, Gaithersburg, Maryland. Acknowledgments: Nuo Therapeutics (Gaithersburg, Maryland) sponsored this study and provided oversight and funding for third-party vendors that supported study operations, data storage, and statistical planning and analysis. Therapies were reimbursed by the Centers for Medicare & Medicaid Services in accordance with Medicare rules.
Daniel Hagan
Ferial Abood
Peter Clausen

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutologous platelet-rich plasma products can significantly vary with respect to platelet concentration, the presence of additional cellularity, and the use of additives. Therefore, the utility of each formulation for treating chronic wounds needs to be established.

objectiveTo establish the efficacy of up to 12 weeks of treatment with Aurix hematogel for healing diabetic foot ulcers against usual and customary care including any wound modality in 129 patients using a Medicare Coverage with Evidence Development paradigm.

methodsThis pragmatic randomized controlled trial was conducted in 28 real-world outpatient wound care sites using an inclusive design that included participants with various health risks, comorbidities (eg, peripheral arterial disease, smoking), and any wound severity (Wagner 1-4).

resultsKaplan-Meier analysis showed a significant (log-rank P = .0476) time-to-heal advantage, with 48.5% of wounds healing with Aurix hematogel compared with 30.2% with usual and customary care. A higher percentage of healing was observed for Aurix across all wound severities (Wagner grade 1-4). Subgroup analysis revealed a significant healing advantage for Aurix when treating wounds accompanied by peripheral arterial disease and a demonstrated advantage for smokers.

conclusionsThis first Coverage with Evidence Development study in wound care demonstrates the effectiveness of Aurix for treating diabetic foot ulcers in Medicare beneficiaries.

Indexed as

Platelet-Rich PlasmaAgedDiabetic FootFemaleGelsHumansKaplan-Meier EstimateMaleMiddle AgedTime FactorsTreatment OutcomeWound HealingGels

Identifiers

PMID31436621
PMCPMC7328869

What OpenQuestion holds

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Registered trials

None linked

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.