Evidence map›Paper›PMID 32393479›Full record

Trial reportBMJ open diabetes research & care2020

Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial.

Louis Potier, Maud François, Dured Dardari, Marilyne Feron, Narimene Belhatem, Estelle Nobecourt-Dupuy, Manuel Dolz, Lyse Bordier, Roxane Ducloux, Abdelkader Chibani and 15 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open diabetes research & care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01956162 (Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT01956162 nacompletednot on this map

Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

TypeinterventionalSponsorProteor GroupRan2013 to 2016Enrolled118ConditionsFoot Ulcer, DiabeticArmsOrthèse Diabète, "Conventional" Device
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 10 citations in OpenAlex.

No citing paper in PubMed yet.

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

25 authors at 12 institutions in 3 countries.

Louis PotierDiabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France louis.potier@gmail.com.ORCID 0000-0001-6268-7360
Maud FrançoisEndocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.
Dured DardariDiabetology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, Paris, France.ORCID 0000-0002-7172-4300
Marilyne FeronDiabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.
Narimene BelhatemDiabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.
Estelle Nobecourt-DupuyDepartment of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Universitaire de la Réunion, Saint Denis de la Réunion, France.
Manuel DolzEndocrinology Department, Hôpital Bégin, Saint-Mandé, France.
Lyse BordierEndocrinology Department, Hôpital Bégin, Saint-Mandé, France.
Roxane DuclouxAPHP, Hôpital Corentin-Celton, Centre de Cicatrisation du Pied du Diabétique, Issy les Moulineaux, France.
Abdelkader ChibaniDepartment of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Gonesse, Gonesse, France.
Dominique-François EvenoDepartment of Functional Rehabilitation, Centre Hospitalier La Tourmaline, La Tourmaline, France.
Teresa Crea AvilaDepartment of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Régional de Metz-Thionville, Thionville, France.
Ariane SultanDepartment of Endocrinology, Diabetology and Nutrition, CHRU Montpellier, Montpellier, France.
Laurence Baillet-BlancoDepartment of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.
Vincent RigalleauDepartment of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.
Elise GandINSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.
Pierre-Jean SaulnierINSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.
Gilberto VelhoINSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France.
Ronan RousselDiabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.
Quentin PellencVascular Surgery Department, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.
Jean-Claude DupréDiabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.
Dominique MalgrangeEndocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.
Michel MarreDiabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.
Kamel MohammediDepartment of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.
ORTHODIAB study group
Université Claude Bernard Lyon 1 · FRInserm · FRCentre Hospitalier Universitaire de Reims · FRHôpital d'Instruction des Armées Bégin · FRUniversité de Bordeaux · FRCentre Hospitalier de Gonesse · FRCentre Hospitalier Sud Francilien · FRCentre Hospitalier Universitaire de La Réunion · FRHôpital Cardiologique du Haut-Lévêque · FRHôpital Corentin-Celton · FRHôpital de la Tour · CHHôpital Femme Mère Enfant · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. RESEARCH, DESIGN AND

methodsThe evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either

resultsAmong 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%)

conclusionsTRIAL REGISTRATION NUMBER: NCT01956162.

Indexed as

Diabetes MellitusDiabetic FootAdultAgedAmputation, SurgicalHumansMaleMiddle AgedWound Healingfoot ulceroff-loading devicesrandomized clinical trialswound healing

Identifiers

PMID32393479
PMCPMC7223015
OpenAlexW3020941534

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.