Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome
Trial ID: NCT06124586
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-02-01
Completion date: 2028-11-01
Sponsor: Heinrich-Heine University, Duesseldorf
Collaborators: German Diabetes Center
Conditions: Diabetic Foot; Diabetes Mellitus; Peripheral Arterial Disease; Diabetic Neuropathies; Diabetic Retinopathy; Anemia; Ulcer Foot; Ulcer Ischemic; Diabetic Polyneuropathy
Interventions: Percutaneous transluminal angioplasty
Locations: University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Countries: Germany
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* 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

Exclusion Criteria:

* Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).
* Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).
* Minors or subjects incapable of giving consent
* Pregnant or breastfeeding women
* Treatment with certain drugs (immunosuppressive therapy,
* Immunomodulators, chemotherapy, antibiotic therapy \< 2 weeks before
* intervention)
* Diseases of the pancreas
* Severe neurological or psychiatric disease
* Known presence of malignant tumor disease within the past 5 years
* Participation in other interventional trials and receipt of investigational medication within the last 30 days
* Blood or plasma donation within the last 3 months

Outcomes:
Effect of PTA within 48h on changes of the wound area