NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS

NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS - NEMUS

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002212-31-IT

Enrollment

Registered

2021-07-06

Start date

2021-09-27

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer MedDRA version: 24.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004858 MedDRA version: 24.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004858 MedDRA version: 24.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004858 MedDRA version: 24.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004

Interventions

Product Name: Udonitrectag Product Code: [MT8 o MT2-L] Pharmaceutical Form: Cutaneous solution INN or Proposed INN: Udonitrectag CAS Number: 1458063-51-8 Current Sponsor code: MT8 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of signed and dated informed consent form; 2. Stated willingness to comply with all study procedures and availability for the duration of the study; 3. Male or female; 4. Age = 18 years; 5. Diagnosis of type 1 or 2 diabetes mellitus; 6. A diabetic foot wound grade I or II, according to the TEXAS diabetic wound classification system (Table 5) and grading 1 in the PEDIS infection scale (Table 6); 7. TpO2= 30 mmHg or ABI (Ankle Brachial Index) = 0.70; 8. Ulcers not healing with standard good care in the last 2-weeks (ulcer area reduction less than 20% versus baseline); 9. Presence of ulcer with an area from 2 to 15 cm2 measured by MolecuLight i:XTM Wound Imaging Device; 10. Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study; 11. Glycated haemoglobin (HbA1c) levels =10% (or = 86 mmol/mol); 12. 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; 13. For males with partners reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: 1. Pregnancy or Lactation. Female patients who are pregnant or breast-feeding; 2. 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; 3. Presence of infected foot ulcer of grade >1 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination; 4. 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); 5. Severe renal failure defined as eGFR10% or >86 mmol/mol); 14. Patients with ulcers due to other etiologies (e.g., arterial insufficiency); 15. Current use of high-dose steroids or immunosuppressants; 16. Febrile illness within one month from Visit 1b; 17. Current smoker; 18. Blood pressure above 180/100 or heart rate>100 bpm or Respiratory frequency >30; 19. Patients who show reductions or enlargement of the ulcer area >20% during the screening phase will not be enrolled for the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To determine and to compare the ability of two doses of udonitrectag in promoting reduction of the ulcer area during 6-week treatment.;Primary end point(s): Safety and tolerability: I.Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events; II.Clinical laboratory results during and following udonitrectag administration; III.Pharmacokinetics.;Timepoint(s) of evaluation of this end point: 8 weeks	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To determine and to compare the ability of two doses of udonitrectag in promoting reduction of the ulcer area during 6-week treatment.;Primary end point(s): Safety and tolerability: I.Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events; II.Clinical laboratory results during and following udonitrectag administration; III.Pharmacokinetics.;Timepoint(s) of evaluation of this end point: 8 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: percentage of ulcer area reduction during 6-week treatment, defined as percentage change area ((Area0 - Areat)/Area0)*100.;Timepoint(s) of evaluation of this end point: 8 weeks	—

Countries

Italy

Contacts

Public Contact-

MimeTech Srl

federico.cozzolino@mimetech.eu

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026