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

Обзор

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.

Подробное описание

The study is targeted to enroll approximately sixty subjects with diabetic foot ulcers. All subjects will be randomized at baseline visits at a 2:1 ratio to either receive the study treatment plus standard of care or standard of care alone.

All subjects who meet inclusion/exclusion criteria will have all ulcers treated; however, only one ulcer, the largest, will be selected as the target ulcer.

Before performing any study procedures, all potential subjects will sign an informed consent form (ICF).

The total study duration is anticipated to be up to 18 weeks, including:

* Up to a 14-day screening period * Up to 12 weeks study treatment * Up to 4 weeks of follow-up * End-of-treatment visit will be performed on the last day of treatment (D84) * End-of-Study visit will be performed at the follow-up visit (D112)

Wound photography should be dedicated to one study site personnel to control variance.

Вмешательства

• Препарат 0.75% MDI-1228_mesylate gel plus Standard of Care
  Approximately 40 subjects will receive 0.75% MDI-1228\_mesylate gel twice daily for 12 weeks.
• Другое Standard of Care Alone
  Approximately 20 subjects will receive the standard of care alone including wound cleaning, debribement and other additional care decided by the healthcare provider.

Первичные конечные точки

• Drug related treatment emergent adverse events [Срок оценки: 1-12 weeks]
• Complete Healing and Time to closure for targeted diabetic foot ulcer [Срок оценки: 1-12 weeks]

Вторичные конечные точки (1)

• Ulcer area reduced by 50% [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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;
• Male or female 18-75 years;
• 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).

Критерии исключения

• Allergy to the main components or excipients of MDI-1228\_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution.
• Skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc.
• The target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment.
• Those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Site 001 — Durham

Идентификаторы

NCT: NCT06852976 · RPT-1228-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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