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

NCT06124586 | Recruiting

• 1 other identifier: PTA-DFS Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetic foot syndrome; peripheral artery disease; diabetic food ulcers; microbiome; percutaneous transluminal angioplasty

Outcome Measures

Primary Outcomes (1)

• Effect of PTA within 48h on changes of the wound area

  Assessment of the impact of 'early' PTA (performed within 48 hours) on wound healing, evaluated through changes in wound area using a 3D camera with an AI-based wound analysis system over a 12-month follow-up period.

  Wound area difference from baseline to last visit

Secondary Outcomes (1)

• Effect of PTA within 48h on the cummulative occurrence of MALE and MACE

  Baseline to one year follow up

Other Outcomes (2)

• Effect of PTA within 48h on changes in wound microbiome

  Baseline to one year follow-up

• Effect of PTA within 48h on changes in oxygen saturation of wound environment

  Baseline to one year follow up

Study Arms (2)

PTA within 48h

EXPERIMENTAL

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.

PTA within 6 weeks

ACTIVE COMPARATOR

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.

Procedure: Percutaneous transluminal angioplasty

Interventions

Percutaneous transluminal angioplasty PROCEDURE

Percutaneous transluminal angioplasty of the leg

PTA within 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• German Diabetes Center: collaborator

Study Sites (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

Related Publications (1)

• Bodis KB, Florea DI, Goh S, Kramser N, Wienemann T, Binsch C, Stern M, Pfeffer K, Kelm M, Roden M, Wagner R, Busch L, Wischmann P; PTA-DFS Study Group. PTA-DFS study: design of a randomised controlled trial assessing the effects of early percutaneous transluminal angioplasty on the healing of diabetic foot ulcers in persons with type 2 diabetes. BMC Cardiovasc Disord. 2025 Nov 14;25(1):811. doi: 10.1186/s12872-025-05288-1.

  PMID: 41239210 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Peripheral Arterial Disease; Diabetic Neuropathies; Diabetic Retinopathy; Anemia; Foot Ulcer

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Retinal Diseases; Eye Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Malte Kelm, Prof.

  Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

  STUDY CHAIR

• Michael Roden, Prof.

  Division of Diabetology and Endocrinology

  STUDY CHAIR

• Hans Lucas Busch, MD

  Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Lucas Busch, MD

CONTACT

+49 (0)211 81 08753; hanslucas.busch@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

+492118105315; lisa.dannenberg@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: November 9, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

DE (1)