Evidence map›Paper›PMID 41239210›Full record

ArticleBMC cardiovascular disorders2025

PTA-DFS study: design of a randomised controlled trial assessing the effects of early percutaneous transluminal angioplasty on the healing of diabetic foot ulcers in persons with type 2 diabetes.

Kálmán B Bódis, David-Ioan Florea, Shouheng Goh, Nicolas Kramser, Tobias Wienemann, Christian Binsch, Manuel Stern, Klaus Pfeffer, Malte Kelm, Michael Roden and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cardiovascular disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06124586 (Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome), which is not on this map. Cited by 1 paper.

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

NCT06124586 narecruitingnot on this map

Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome

TypeinterventionalSponsorHeinrich-Heine University, DuesseldorfRan2024 to 2028Enrolled200ConditionsDiabetic Foot, Diabetes Mellitus, Peripheral Arterial Disease, Diabetic NeuropathiesArmsPercutaneous transluminal angioplasty
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

14 authors.

Kálmán B Bódis *Department of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany. kalman.bodis@ddz.de.ORCID 0000-0002-6248-1554
David-Ioan Florea *Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.ORCID 0009-0008-5438-6435
Shouheng GohDepartment of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany.ORCID 0009-0007-5636-2536
Nicolas KramserDepartment of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.
Tobias WienemannInstitute of Medical Microbiology and Hospital Hygiene, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany.ORCID 0000-0002-1157-8700
Christian BinschDepartment of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany.ORCID 0000-0001-5124-4011
Manuel SternDepartment of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.ORCID 0000-0001-5834-2757
Klaus PfefferInstitute of Medical Microbiology and Hospital Hygiene, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany.ORCID 0000-0002-5652-6330
Malte KelmDepartment of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.ORCID 0000-0003-0060-1052
Michael RodenDepartment of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany.ORCID 0000-0001-8200-6382
Robert WagnerDepartment of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany.ORCID 0000-0002-6120-0191
Lucas Busch *Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.ORCID 0000-0002-5521-1265
Patricia Wischmann *Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany. patricia.wischmann@med.uni-duesseldorf.de.ORCID 0000-0002-7442-6915
PTA-DFS Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeripheral arterial disease (PAD) and local infections increase the risk of non-healing diabetic foot ulcers (DFU) and limb amputations but are treatable by percutaneous transluminal angioplasty (PTA), local wound care and antibiotic therapy. The exact time to treat chronic leg artery stenosis (LAS) and the role of microbiome composition in DFU remain unclear. This study aims to assess whether an early PTA within 48 h after diagnosing a LAS offers advantages over standard care.

methodsThe PTA-DFS Study is a randomised controlled monocentric trial including individuals with T2D and DFU, aged > 18 years with haemodynamically relevant chronic LAS. The primary study endpoint is to investigate the impact of the early PTA within 48 h on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and safety-related cardiac events (MACE) over 12 month post-angioplasty using time-to-event analysis. Additional secondary outcomes are time to complete wound healing, major amputation rate and the need for new revascularization. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Data will be collected at baseline, 24 h, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, LAS will be assessed by laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography. DISCUSSION: The PTA-DFS aims to improve diagnostic and therapeutic algorithms, risk assessment and enable tailored therapies for persons with T2D and ischemic DFU.

trial registrationTrial Registration Number: NCT06124586 (Registration Date: 2023-08-2).

Indexed as

AngioplastyDiabetes Mellitus, Type 2Diabetic FootPeripheral Arterial DiseaseWound HealingAgedAmputation, SurgicalFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicRisk FactorsTime FactorsTreatment OutcomeDiabetic foot syndromeDiabetic foot ulcersPercutaneous transluminal angioplastyPeripheral artery diseaseWound microbiome

Identifiers

PMID41239210
PMCPMC12619298

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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.