Evidence map›Paper›PMID 34748565›Full record

Trial reportPloS one2021

Long-term foot outcomes following differential abatement of inflammation and osteoclastogenesis for active Charcot neuroarthropathy in diabetes mellitus.

Liza Das, Ashu Rastogi, Edward B Jude, Mahesh Prakash, Pinaki Dutta, Anil Bhansali

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03289338 (Zoledronic Acid or Methylprednisolone in the Management of Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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.

NCT03289338 phase2 / phase3completednot on this map

Zoledronic Acid or Methylprednisolone in the Management of Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus: A Randomized, Double-blind, Placebo Controlled Trial

TypeinterventionalSponsorPost Graduate Institute of Medical Education and Research, ChandigarhRan2016 to 2018Enrolled36ConditionsCharcot Arthropathy, Diabetes ComplicationsArmsZoledronic Acid, Methylprednisolone, Placebos
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Burning Issues/Hot Topics: The Charcot Foot.Journal of clinical medicine · 2026
    Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. 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

6 authors at 2 institutions in 2 countries.

Liza DasDepartment of Endocrinology, PGIMER, Chandigarh, India.
Ashu RastogiDepartment of Endocrinology, PGIMER, Chandigarh, India.ORCID 0000-0002-9375-3102
Edward B JudeTameside and Glossop Integrated Care NHS Foundation Trust, Ashton on Lyne, United Kingdom.
Mahesh PrakashDepartment of Radiodiagnosis, PGIMER, Chandigarh, India.
Pinaki DuttaDepartment of Endocrinology, PGIMER, Chandigarh, India.
Anil BhansaliDepartment of Endocrinology, PGIMER, Chandigarh, India.
Post Graduate Institute of Medical Education and Research · INTameside and Glossop Integrated Care NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsInflammatory osteolysis is sine-qua-non of active Charcot neuroarthropathy (CN) causing decreased foot bone mineral density (BMD) and fractures. We aimed to explore the effect of anti-inflammatory or anti-resorptive agents for effect on foot bone mineral content (BMC) and consequent long-term outcomes of foot deformities, fractures and amputation.

methodsForty-three patients with active CN (temperature difference >2°C from normal foot) were evaluated. Patients were off-loaded with total contact cast and randomized to receive either methylprednisolone (1gm) (group A), zoledronate (5mg) (group B) or placebo (100ml normal saline) (group C) once monthly infusion for three consecutive months. Change in foot BMC was assessed at 6 months or at remission and followed subsequently up to 4 years for the incidence of new-onset fracture, deformities, or CN recurrence.

resultsThirty-six participants (24 male, 12 female) were randomized (11 in group A, 12 group B, 13 group C). The mean age was 57.7± 9.9 years, duration of diabetes 12.3± 5.8 years and symptom duration 6.5± 2.8 weeks. BMC increased by 36% with zoledronate (p = 0.02) but reduced by 13% with methylprednisolone (p = 0.03) and 9% (p = 0.09) with placebo at remission. There were no incident foot fractures, however, two patients sustained ulcers, and 3 had new-onset or worsening deformities and none required amputation during 3.36 ± 0.89 years of follow-up.

conclusionBisphosphonate for active CN is associated with an increase in foot bone mineral content as compared to decrease with steroids or total contact cast but long-term outcomes of foot deformities, ulceration and amputation are similar.

trial registrationClinicalTrials.gov: NCT03289338.

Indexed as

Anti-Inflammatory AgentsArthropathy, NeurogenicBone DensityBone Density Conservation AgentsDiabetes Mellitus, Type 2Diabetic FootDiabetic NeuropathiesFemaleHumansInflammationMaleMethylprednisoloneMiddle AgedOsteogenesisTreatment OutcomeZoledronic AcidAnti-Inflammatory AgentsBone Density Conservation AgentsMethylprednisoloneZoledronic Acid

Identifiers

PMID34748565
PMCPMC8575293
OpenAlexW3212087372

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.