NCT06124586: PTA-DFS

Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)

Recruiting now NA Last updated 4 February 2026

What this trial tests

NA trial testing Percutaneous transluminal angioplasty in Diabetic Foot in 200 participants. Currently enrolling.

Timeline

1 February 2024

Primary endpoint
1 February 2028

1 November 2028

Quick facts

Lead sponsor	Heinrich-Heine University, Duesseldorf
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 February 2024
Primary completion	1 February 2028
Estimated completion	1 November 2028
Sites	1 location across Germany

Drugs / interventions tested

• Percutaneous transluminal angioplasty

Conditions studied

• Diabetic Foot — all drugs for Diabetic Foot →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Diabetic Neuropathies — all drugs for Diabetic Neuropathies →

Sponsor

Heinrich-Heine University, Duesseldorf

Who can join

18 and older, any sex, with Diabetic Foot or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness ("immediate" treatment, within 48h) has advantages over the "standard of care", i.e., an elective procedure ("elective PTA") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the "early PTA" within 48 hours 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 cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. 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. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Bódis KB, Florea DI, Goh S, Kramser N, et al · · 2025 · PMID 41239210 · DOI 10.1186/s12872-025-05288-1