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

Sponsor
Heinrich-Heine University, Duesseldorf
Study ID
NCT06124586
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous transluminal angioplasty — PROCEDURE
    Percutaneous transluminal angioplasty of the leg

Study Details

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.

Key Dates

First listed
Nov 9, 2023
Start date
Feb 1, 2024
Status verified
Feb 2026
Primary completion
Feb 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PTA within 48h
    A study participant in this group will receive a PTA in 'readiness', which means within 48 hours after diagnosis of a flow-limiting leg artery stenosis.
  • Active Comparator: PTA within 6 weeks
    A study participant in this group will receive a PTA according to the international guidelines, which means within 6 weeks after diagnosis of a flow-limiting leg artery stenosis.

Primary Outcome Measure

Effect of PTA within 48h on changes of the wound area [ Time Frame: Wound area difference from baseline to last visit ]

Central Contacts

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