NCT06124586Recruiting
Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)
Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 21 Aug 2023
- Start date
- 1 Feb 2024
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Diseases
- Type 2 diabetes, Diabetic eye disease
- NCT number
- NCT06124586
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Feb 2024 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with certain drugs (immunosuppressive therapy,
- Immunomodulators, chemotherapy, antibiotic therapy \< 2 weeks before
- Participation in other interventional trials and receipt of investigational medication within the last 30 days
Other illness
- Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).
- Diseases of the pancreas
- Severe neurological or psychiatric disease
- Known presence of malignant tumor disease within the past 5 years
Other
- Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).
- Minors or subjects incapable of giving consent
- Pregnant or breastfeeding women
- intervention)
- Blood or plasma donation within the last 3 months
Who the study is looking for
- volunteer adults
- written informed consent
- presence of known manifest T2D and fulfilment of the following criteria:
- HbA1c \< 10%
- presence of pAVD with fulfillment of the following criteria:
- PAD Stage After Fontaine IV (foot ulcer)
- Presence of foot ulcer with fulfillment of the following criteria:
- Foot ulceration without indication for emergency surgical care from stage Wagner 1.
- Age \>18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.