Evidence map›Paper›PMID 30616671›Full record

Trial reportArthritis research & therapy2019

Regional grafting of autologous adipose tissue is effective in inducing prompt healing of indolent digital ulcers in patients with systemic sclerosis: results of a monocentric randomized controlled study.

Nicoletta Del Papa, Gabriele Di Luca, Romina Andracco, Eleonora Zaccara, Wanda Maglione, Francesca Pignataro, Antonina Minniti, Claudio Vitali

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
6.6field-weighted citation impact, top 2% 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.

NCT03406988 naunknown statusnot on this map

Regional Grafting of Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers: a Prospective Randomized Controlled Study

TypeinterventionalSponsorASST Gaetano Pini-CTORan2017 to 2018Enrolled46ConditionsSystemic Sclerosis, Digital UlcerArmsAutologous fat grafting, Sham procedure
NCT05016804 phase1recruitingnot on this mapstarted 2022, after this paper: background citation

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis

TypeinterventionalSponsorThe Foundation for Orthopaedics and Regenerative MedicineRan2022 to 2026Enrolled20ConditionsSystemic SclerosisArmsAlloRx
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Stem cell therapy in systemic sclerosis.Clinical rheumatology · 2025
    Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Autologous Fat Grafting: Evaluation of Efficacy in Pain Relief.Plastic and reconstructive surgery. Global open · 2022
    Article
  20. 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

8 authors at 2 institutions in 1 country.

Nicoletta Del PapaU.O.C. Day Hospital Reumatologia, ASST G. Pini-CTO, Milan, Italy. nicoletta.delpapa@gpini.it.
Gabriele Di LucaU.O.S. Chirurgia Vascolare, ASST G. Pini-CTO, Milan, Italy.
Romina AndraccoU.O.C. Day Hospital Reumatologia, ASST G. Pini-CTO, Milan, Italy.
Eleonora ZaccaraU.O.C. Day Hospital Reumatologia, ASST G. Pini-CTO, Milan, Italy.
Wanda MaglioneU.O.C. Day Hospital Reumatologia, ASST G. Pini-CTO, Milan, Italy.
Francesca PignataroU.O.C. Day Hospital Reumatologia, ASST G. Pini-CTO, Milan, Italy.
Antonina MinnitiU.O.C. Day Hospital Reumatologia, ASST G. Pini-CTO, Milan, Italy.
Claudio VitaliSections of Rheumatology, Villa S. Giuseppe, Como and Casa di Cura di Lecco, Lecco, Italy.
Istituto Ortopedico Gaetano Pini · ITCasa di Cura San Michele · IT

Funding

SIR, Società italiana Reumatologia 2015
6 · The paper itself

Abstract

backgroundA randomized controlled trial (RCT) was performed to confirm preliminary uncontrolled data indicating that regional adipose tissue (AT) grafting (G) is effective in inducing ischemic digital ulcer (IDU) healing in patients with systemic sclerosis (SSc). PATIENTS AND

methodsSSc patients with IDUs were randomized to be blindly treated with AT-G or a sham procedure (SP). AT-G consisted of injection, at the base of the finger with the IDU, of 0.5-1 ml AT after centrifugation of fat aspirate. The SP consisted of false liposuction and local injection of saline solution. The primary endpoint was to compare the cumulative prevalence of healed IDUs in the two groups within the following 8 weeks.

resultsAT-G and the SP were carried out in 25 and 13 patients, respectively. The two groups were comparable for age, gender, disease duration, and SSc subtypes. IDU healing was observed in 23/25 and 1/13 patients treated with AT-G and the SP, respectively (p < 0.0001). The 12 patients who received the unsuccessful SP underwent a rescue AT-G. In all of them, IDU healing was observed after 8 weeks of observation. It was noticeable that in the AT-G-treated patients a significant reduction of pain intensity (measured by visual analogue scale) was recorded after 4 and 8 weeks (p < 0.0001 in all cases). Similarly, a significant increase of capillary numbers in the affected finger was recorded by nailfold videocapillaroscopy after 4 and 8 weeks (p < 0.0001 in both cases).

conclusionThis RCT strongly confirms that AT-G is effective in inducing IDU healing in SSc patients.

trial registrationClinicalTrials.gov, NCT03406988 . Registered retrospectively on 25 January 2018.

Indexed as

Adipose TissueAdultAgedAutograftsFemaleFingersFollow-Up StudiesHumansMaleMiddle AgedScleroderma, SystemicSkin UlcerTissue TransplantationTreatment OutcomeWound HealingYoung AdultAdipose tissue stem cellsAutologous fat graftingDigital ulcersSystemic sclerosis

Identifiers

PMID30616671
PMCPMC6322261
OpenAlexW2946850386

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.