Evidence map›Paper›PMID 29270004›Full record

Trial reportDrug design, development and therapy2017

EUREKA study - the evaluation of real-life use of a biophotonic system in chronic wound management: an interim analysis.

Marco Romanelli, Alberto Piaggesi, Giovanni Scapagnini, Valentina Dini, Agata Janowska, Elisabetta Iacopi, Carlotta Scarpa, Stéphane Fauverghe, Franco Bassetto

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Fluorescent Light Energy and Chronic Lesions: A Winning Association.Plastic and reconstructive surgery. Global open · 2021
    Article
  7. Review
  8. Article
  9. 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.

Marco RomanelliWound Healing Research Unit, Division of Dermatology, School of Medicine, University of Pisa, Pisa.
Alberto PiaggesiDiabetic Foot Section, Department of Medicine, University of Pisa, Pisa.
Giovanni ScapagniniDepartment of Medicine and Health Sciences, School of Medicine, University of Molise, Campobasso.
Valentina DiniWound Healing Research Unit, Division of Dermatology, School of Medicine, University of Pisa, Pisa.
Agata JanowskaWound Healing Research Unit, Division of Dermatology, School of Medicine, University of Pisa, Pisa.
Elisabetta IacopiDiabetic Foot Section, Department of Medicine, University of Pisa, Pisa.
Carlotta ScarpaClinic of Plastic and Reconstructive Surgery, Padova University-Hospital, Padova, Italy.
Stéphane FauvergheKLOX Technologies Inc., Laval, QC, Canada.
Franco BassettoClinic of Plastic and Reconstructive Surgery, Padova University-Hospital, Padova, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInterest has grown regarding photobiomodulation (PBM) with low-level light therapy, which has been shown to positively affect the stages of the wound healing process. In a real-life context clinical setting, the objective of the EUREKA study was to investigate efficacy, safety, and quality of life associated with the use of a BioPhotonic gel (LumiHeal™) in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs). This BioPhotonic gel represents a new, first-in-class emission spectrum of light, including fluorescence, to induce PBM and modulate healing.

designThe multicenter, prospective, interventional, uncontrolled, open-label study enrolled 100 patients in 12 wound centers in Italy. We performed an early interim analysis based on the first 33 subjects (13 VLU, 17 DFU, 3 PU) in seven centers who completed the study. MAIN

resultsSeventeen patients (52%) achieved total wound closure (full re-epithelialization for 2 weeks) during the study period. Two patients (6%) were considered "almost closed" (decrease of the wound area of more than 90% at study end) and three others (9%) were considered "ready for skin grafting". No related serious adverse events were observed, and the compliance was excellent. After the treatment, the average time to "pain-free" was 11.9 days in the VLU group. Quality of life was improved with overall increase of 26.4% of the total score (Cardiff Wound Impact Schedule,

conclusionThe study revealed a positive efficacy profile of the BioPhotonic gel in promoting wound healing and reactivating the healing process in different types of chronic, hard-to-heal wounds. The treatment was shown to be safe and well tolerated by the patients, and a reduction of pain perception was also detected during the treatment period. The improvement of the quality of life was accompanied by a high level of clinician satisfaction.

Indexed as

FluorescencePhototherapyAgedChronic DiseaseGelsHumansItalyProspective StudiesQuality of LifeUlcerWound HealingGelsbiophotonicsDFUsdiabetic foot ulcersfluorescence biomodulationhard-to-heal woundslightphotobiomodulationphototherapypressure ulcersPUsvenous leg ulcersVLUs

Identifiers

PMID29270004
PMCPMC5729886

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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.