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

Summary

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.

Conditions

• Diabetic Foot
• Diabetes Mellitus
• Peripheral Arterial Disease
• Diabetic Neuropathies
• Diabetic Retinopathy
• Anemia
• Ulcer Foot
• Ulcer Ischemic
• Diabetic Polyneuropathy

Interventions

PROCEDURE

Percutaneous transluminal angioplasty

Percutaneous transluminal angioplasty of the leg

Sponsors & Collaborators

• German Diabetes Center

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  lead OTHER

Principal Investigators

• Malte Kelm, Prof. · Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

• Michael Roden, Prof. · Division of Diabetology and Endocrinology

• Hans Lucas Busch, MD · Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2028-02-01

Completion

2028-11-01

Countries

• Germany

Study Locations