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New treatment option for Diabetic Foot
Official title Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)
ClinicalTrials.gov ID: NCT06124586
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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:
You likely can't join 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 people incapable of giving consent
- Pregnant or breastfeeding women
- Treatment with certain drugs (immunosuppressive therapy,
- Immunomodulators, chemotherapy, antibiotic therapy \< 2 weeks before
See the full eligibility 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
- 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 people 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 treatment trials and receipt of investigational medication within the last 30 days
- Blood or plasma donation within the last 3 months
The study team makes the final eligibility decision.
Where it's taking place
- Düsseldorf, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Düsseldorf, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.