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

Study acronym: PTA-DFS
StatusRecruiting
PhaseNot applicable
Started2024-02-01
View on ClinicalTrials.gov ↗

Amendment history

2026-02-03
minor
Study Identification, Study Status, Oversight, Arms and Interventions, Contacts/Locations, IPDSharing v4
Study sitescontacts updated at 1 of 1 site
2024-12-09
minor
Study Identification, Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v3
Interventionspercutaneous transluminal angioplasty (Procedure)→Percutaneous transluminal angioplasty (Procedure)
Eligibility criteria-2 characters
[...] indication for emergency surgical care from stage Wagner 1. - Age >18 years Exclusion Criteria: Acute leg ischemia (sudden [...]
Secondary endpoints3 to 1 entries
the effect of the immediate PTA intervention on overall wound-healing Effect of the immediate PTA interventionwithin 48h on microcircularion Effectthe cummulative occurrence of theMALE immediateand PTA intervention on related complicationsMACE
Primary endpoints1 entry, revised
effectEffect of anPTA immediate (within first 48h) PTA intervention on microbiomechanges compositionof the wound area
Study description+3,518 characters
The planned study is a monocentric, randomized, and controlled clinical trial. Study participants will be randomized in a 1:1 ratio into atwo groupgroups: withone receiving early PTA ("immediate PTA", within 48h48 hours after diagnosing a hemodynamically relevant chronic leg artery stenosis) and athe groupother withreceiving elective PTA (standard of care). Baseline and all follow-up examinations will be performed identically in both groups, except for the timing of PTA. TheAlthough the study is unblinded tofor theboth patientsparticipants and physicians due to practical feasibility, i.blindin [...] [...]
Study sitescontacts updated at 1 of 1 site
2024-02-15
minor
Study Status, Eligibility v2
Start date2023-02-01→2024-02-01
Eligibility criteria-57 characters
[...] t ulceration without indication for emergency surgical care (No sepsis, osteomyelitis) from stage Wagner 1. - Age between >18 and 70 years BMI 20 - 45 kg/m2 Exclusion Criteria: Acute leg ischemia (sudden onset, sensor [...]
2024-02-05
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-09-01→2028-02-01
Completion date2028-09-01→2028-11-01
Start dateestimated 2023-11-10→confirmed 2023-02-01
Study sitesdetails revised at 1 of 1 site
2023-11-08
minor
Original filing
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.
Trial Details
NCT Number NCT06124586
Lead 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 +1 more
Enrollment 200 participants
Start Date 2024-02-01
Primary Completion 2028-02-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-04