Evidence map›Paper›PMID 30431560›Full record

Trial reportMedicine2018

Brief topical sodium nitrite and its impact on the quality of life in patients with sickle leg ulcers.

Joseph L Connor, Joseph A Sclafani, Gregory J Kato, Matthew M Hsieh, Caterina P Minniti

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 30% 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.

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, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Interventions for treating leg ulcers in people with sickle cell disease.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Leg ulcers in sickle cell disease patients.Jornal vascular brasileiro · 2020
    Review
  4. 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

5 authors at 4 institutions in 1 country.

Joseph L ConnorRehabilitation Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD.
Joseph A SclafaniRehabilitation Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD.
Gregory J KatoPittsburgh Heart, Lung and Blood Vascular Medicine Institute.
Matthew M HsiehNational Heart, Lung, and Blood Institute and National Institute of Diabetes, Digestive, and Kidney Diseases, National Institutes of Health, Bethesda, MD.
Caterina P MinnitiDivision of Hematology, Department of Oncology, Montefiore Medical Center, Bronx, NY, USA.
MedStar National Rehabilitation Hospital · USMontefiore Medical Center · USNational Institutes of Health · USUniversity of Pittsburgh · US

Funding

CTSA Administrative Supplement for Informatics Core: A novel AI/ML system to predict respiratory failure and ARDS in Covid-19 patientsUL1TR002556 · NCATS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI KELLER, MARLA J, KIM, MIMI Y · 2018 to 2022
$26.7M
NCATS NIH HHS UL1 TR002556
6 · The paper itself

Abstract

Cutaneous ulceration from sickle cell disease negatively impacts quality of life. Topical sodium nitrite has previously been shown to reduce the size of sickle leg ulcers. This study examined how topical sodium nitrite impacted the quality of life scores in patients with sickle leg ulcers.We prospectively collected data in patients enrolled in a leg ulcer study (n = 17) or an allogeneic hematopoietic cell transplant study (nonulcer group, n = 15). Both groups completed a pretreatment Short Form-36 questionnaire; the ulcer group completed a second questionnaire after 4 weeks of topical sodium nitrite applications. Data were analyzed by age, sex, >50% area improvement postintervention, and sickle-related complications (vaso-occlusive crises, pulmonary hypertension, or avascular necrosis). Physical and mental component summary scores were analyzed with Student t test.Physical summary scores were lower than mental summary scores in all groups, indicating leg ulcers among other sickle related complications negatively impacted physical quality of life measures. After sodium nitrite use, physical summary scores improved in the leg ulcer group (34.5 ± 9.4 to 39 ± 10.3, P = .03), and mental summary scores improved more in ulcerated patients ≤35 years old (40.7 ± 6.9 to 51.7 ± 9.7, P = .01).Brief topical sodium nitrite has the potential to improve quality of life, especially in younger individuals. Longer treatment duration and randomized-controlled trials are needed to confirm the efficacy of this topical therapy.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAdministration, TopicalAdolescentAdultAnemia, Sickle CellFemaleHematopoietic Stem Cell TransplantationHumansLeg UlcerMaleMiddle AgedPreoperative PeriodProspective StudiesSodium NitriteTreatment OutcomeSodium Nitrite

Identifiers

PMID30431560
PMCPMC6257663
OpenAlexW2900723257

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.