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NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS
EU CTIS ID: 2024-519405-35-00
What this study is testing
To determine the safety, tolerability, and pharmacokinetic profile of udonitrectag (MT8) added to standard of care versus standard of care alone in the treatment of Diabetic Foot Ulcers.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of signed and dated informed consent form;
- Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study;
- Glycated haemoglobin (HbA1c) levels <=10% (or <= 86 mmol/mol)
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
- For males with partners reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- Stated willingness to comply with all study procedures and availability for the duration of the study;
You likely can't join if
- Pregnancy or Lactation. Female patients who are pregnant or breast-feeding;
- Diagnosis of current of autoimmune disorders;
- Immunosuppressed subjects;
- History of any medical or psychiatric conditions that, according to the Investigator, may increase the risks associated with the study’s participation or investigational product(s) administration;
- Patients with diabetes under poor control (HbA1c of >10% or >86 mmol/mol);
- Patients with ulcers due to other etiologies (e.g., arterial insufficiency);
See the full eligibility criteria
- Provision of signed and dated informed consent form;
- Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study;
- Glycated haemoglobin (HbA1c) levels <=10% (or <= 86 mmol/mol)
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
- For males with partners reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Male or female;
- Age >=18 years;
- Diagnosis of type 1 or 2 diabetes mellitus;
- A diabetic foot wound grade I or II, according to the TEXAS diabetic wound classification system and grading 1 in the PEDIS infection scale;
- TpO2>= 30 mmHg or ABI (Ankle Brachial Index) >= 0.70;
- Ulcers not healing with standard good care in the last 2-weeks (ulcer area reduction less than 20% versus baseline);
- Presence of ulcer with an area from 2 to 15 cm2 measured by MolecuLight i:XTM Wound Imaging Device;
- Pregnancy or Lactation. Female patients who are pregnant or breast-feeding;
- Diagnosis of current of autoimmune disorders;
- Immunosuppressed subjects;
- History of any medical or psychiatric conditions that, according to the Investigator, may increase the risks associated with the study’s participation or investigational product(s) administration;
- Patients with diabetes under poor control (HbA1c of >10% or >86 mmol/mol);
- Patients with ulcers due to other etiologies (e.g., arterial insufficiency);
- Current use of high-dose steroids or immunosuppressants;
- Febrile illness within one month from Visit 1b;
- Current smoker;
- Blood pressure above 180/100 or heart rate>100 bpm or Respiratory frequency >30;
- Patients who show reductions or enlargement of the ulcer area >20% during the screening phase will not be enrolled for the study.
- Childbearing potential female patients who do not agree to use an acceptable method of contraception during the study, providing they are not pregnant or lactating;
- Presence of infected foot ulcer of grade >1 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination;
- Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to study treatment (Visit 1a o Visit 1b);
- Severe renal failure defined as eGFR< 30 ml/min;
- Clinical diagnosis of peripheral vascular disease (PVD) requiring a prompt revascularization;
- Any surgery planned in the study period, including scheduled amputation at the ulcer site;
- Diagnosis of severe medical conditions such as severe heart failure or severe hepatic disease, according to the Investigator’s judgment or presence of concurrent illness indicating a short life expectancy;
- Diagnosis of current cancer;
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.