RECRUITING

The Purpose of This Study is to Evaluate the Efficacy and the Safety of MDI-1228 Mesylate Gel Compared With Standard of Care Alone in Patients With Chronic Diabetic Foot Ulcers

Conditions

Diabetic Foot Ulcer Diabetic Foot Ulcers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer). In addition, the proportion of subjects whose target ulcer area is reduced by 50% after 12 weeks of treatment.

Official Title

A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers

Quick Facts

Study Start:2025-02

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06852976

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures; 2. Male or female 18-75 years; 3. Meet diagnostic criteria for a diabetic ulcer with the presence of at least one target ulcer that meets the characteristics: * Located on dorsal or plantar surface of foot or below the knee. * Wagner grade 2, ulcerated lesion at or below the knee, without systemic infection. * The target ulcer should be the largest, and all each individual ulcers size should be less than 25cm2. All ulcers will be treated the same as the target ulcer. * Target ulcers persisted for at least 12 weeks prior to enrollment and have been on standard of care for at least 4 weeks prior to enrollment. * There is a minimum 3cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post-debridement). 4. Subjects of child-bearing potential and their sexual partners do not plan to become pregnant within 3 months after the last dose of the investigational drug. Subjects must voluntarily use effective contraception. Male subjects must not plan to donate sperm. 5. Subjects must be willing to attend scheduled visits, follow study procedures and be able to provide written informed consent for the study. 6. History of documented Diabetes Mellitus (DM), Hb A1c should be lower than 12 or also can be within normal range due to control of DM from medications. 7. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) \>0.8 and \<1.3. 8. No active infection on all ulcers wound area by clinical inspection.	1. Allergy to the main components or excipients of MDI-1228_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution. 2. Skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc. 3. The target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment. 4. Those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc. 5. The presence of a serious clinical infection, such as cellulitis, osteomyelitis, etc. or suspected malignant lesion at the site of the ulcerative lesion, or with other serious complications that may interfere with the healing of the ulcer/wound or affect the evaluation. 6. The ulcer site is accompanied by destruction of the joint capsule or bone, or there are sinus tracts that cannot be cleared by debridement. 7. Subjects on medications that are strong inhibitors of CYP2C8 and CYP3A4. 8. Leukocyte count \< 2×109/L or neutrophil \< 1×109/L or platelet count \<80x109/L or hemoglobin \< 90 g/L in screening period. 9. Albumin ALB \< 30 g/L in screening period. 10. ALT, AST \> 3 × ULN, total bilirubin TB \> 1.5 × ULN; serum creatinine Cr \> 2 × ULN in screening period. 11. Subject with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg). 12. Subject with myocardial infarction, severe or unstable angina pectoris, class III or IV congestive heart failure defined by New York Heart Association (NYHA), or the presence of an arrhythmia clinically warranting intervention within 6 months prior to screening. 13. Acute complications of diabetes occurred within 6 months before screening, such as diabetic ketoacidosis, lactic acidosis, hyperosmolar hyperglycemic syndrome, or diabetic hyperosmolar coma. 14. Vascular reconstruction of the affected limb where the target ulcer is located within 3 months prior to screening. 15. Subject has participated in other clinical trials of new drugs or medical devices within 3 months prior to screening and used investigational drugs or medical devices. 16. Subject who has received a live vaccine within 1 month prior to the first dose or is scheduled to receive a live vaccine during the study period. The live vaccines include, but are not limited to measles, mumps, rubella, varicella, yellow fever, rabies, BCG, and typhoid vaccine etc. 17. Known active infections, e.g., bacterial, fungal, and viral infections, including human immunodeficiency virus infection (defined as HIV antibody positive), hepatitis B virus (HBV) infection \[defined as Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥1000 cps/mL or 200 IU/mL\] and hepatitis C virus (HCV) infection (defined as anti-HCV antibody positive and HCV-RNA positive). Human Immunodeficiency Virus (HIV) positive patients could be eligible after discussion with medical monitor based on current status of HIV treatment. 18. Subject has used any immunosuppressant (e.g., systemic corticosteroids) within 4 weeks prior to screening; any topical steroids, topical antibiotics, or trauma biologics (e.g., cytokines) for the target wound within 2 weeks prior to screening; or any systemic or topical therapeutic medications or nutraceuticals (including herbal remedies) and treatments that may affect wound healing. 19. In the opinion of the investigator based on subject's medical history, the subject may have psychiatric condition (e.g., suicidal ideation), current or chronic drug abuse, that may pose a threat to the subject's adherence. 20. Pregnant or breastfeeding female patients. 21. In the opinion of the investigator, the subject has other conditions at the ulcer site that would otherwise make them unsuitable for participation in this study i.e visible skin diseases, sunburns, excessively deep tans, tattoos, scars etc.

Inclusion Criteria

Exclusion Criteria

1. Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures;
2. Male or female 18-75 years;
3. Meet diagnostic criteria for a diabetic ulcer with the presence of at least one target ulcer that meets the characteristics:
* Located on dorsal or plantar surface of foot or below the knee.
* Wagner grade 2, ulcerated lesion at or below the knee, without systemic infection.
* The target ulcer should be the largest, and all each individual ulcers size should be less than 25cm2. All ulcers will be treated the same as the target ulcer.
* Target ulcers persisted for at least 12 weeks prior to enrollment and have been on standard of care for at least 4 weeks prior to enrollment.
* There is a minimum 3cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post-debridement).
4. Subjects of child-bearing potential and their sexual partners do not plan to become pregnant within 3 months after the last dose of the investigational drug. Subjects must voluntarily use effective contraception. Male subjects must not plan to donate sperm.
5. Subjects must be willing to attend scheduled visits, follow study procedures and be able to provide written informed consent for the study.
6. History of documented Diabetes Mellitus (DM), Hb A1c should be lower than 12 or also can be within normal range due to control of DM from medications.
7. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) \>0.8 and \<1.3.
8. No active infection on all ulcers wound area by clinical inspection.

1. Allergy to the main components or excipients of MDI-1228_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution.
2. Skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc.
3. The target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment.
4. Those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.
5. The presence of a serious clinical infection, such as cellulitis, osteomyelitis, etc. or suspected malignant lesion at the site of the ulcerative lesion, or with other serious complications that may interfere with the healing of the ulcer/wound or affect the evaluation.
6. The ulcer site is accompanied by destruction of the joint capsule or bone, or there are sinus tracts that cannot be cleared by debridement.
7. Subjects on medications that are strong inhibitors of CYP2C8 and CYP3A4.
8. Leukocyte count \< 2×109/L or neutrophil \< 1×109/L or platelet count \<80x109/L or hemoglobin \< 90 g/L in screening period.
9. Albumin ALB \< 30 g/L in screening period.
10. ALT, AST \> 3 × ULN, total bilirubin TB \> 1.5 × ULN; serum creatinine Cr \> 2 × ULN in screening period.
11. Subject with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
12. Subject with myocardial infarction, severe or unstable angina pectoris, class III or IV congestive heart failure defined by New York Heart Association (NYHA), or the presence of an arrhythmia clinically warranting intervention within 6 months prior to screening.
13. Acute complications of diabetes occurred within 6 months before screening, such as diabetic ketoacidosis, lactic acidosis, hyperosmolar hyperglycemic syndrome, or diabetic hyperosmolar coma.
14. Vascular reconstruction of the affected limb where the target ulcer is located within 3 months prior to screening.
15. Subject has participated in other clinical trials of new drugs or medical devices within 3 months prior to screening and used investigational drugs or medical devices.
16. Subject who has received a live vaccine within 1 month prior to the first dose or is scheduled to receive a live vaccine during the study period. The live vaccines include, but are not limited to measles, mumps, rubella, varicella, yellow fever, rabies, BCG, and typhoid vaccine etc.
17. Known active infections, e.g., bacterial, fungal, and viral infections, including human immunodeficiency virus infection (defined as HIV antibody positive), hepatitis B virus (HBV) infection \[defined as Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥1000 cps/mL or 200 IU/mL\] and hepatitis C virus (HCV) infection (defined as anti-HCV antibody positive and HCV-RNA positive). Human Immunodeficiency Virus (HIV) positive patients could be eligible after discussion with medical monitor based on current status of HIV treatment.
18. Subject has used any immunosuppressant (e.g., systemic corticosteroids) within 4 weeks prior to screening; any topical steroids, topical antibiotics, or trauma biologics (e.g., cytokines) for the target wound within 2 weeks prior to screening; or any systemic or topical therapeutic medications or nutraceuticals (including herbal remedies) and treatments that may affect wound healing.
19. In the opinion of the investigator based on subject's medical history, the subject may have psychiatric condition (e.g., suicidal ideation), current or chronic drug abuse, that may pose a threat to the subject's adherence.
20. Pregnant or breastfeeding female patients.
21. In the opinion of the investigator, the subject has other conditions at the ulcer site that would otherwise make them unsuitable for participation in this study i.e visible skin diseases, sunburns, excessively deep tans, tattoos, scars etc.

Contacts and Locations

Study Contact

Amanda Fu, M.D.,MBA

CONTACT

3910204908

amanda.fu@d2vclinical.com

Study Locations (Sites)

Avacare

Durham, North Carolina, 27709

United States

Collaborators and Investigators

Sponsor: Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-02

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Diabetic Foot Ulcers

Additional Relevant MeSH Terms

Diabetic Foot Ulcer