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Compares treatment options for Diabetic Foot Ulcer
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
ClinicalTrials.gov ID: NCT06852976
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- 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 to 75
You may be able to join if
- Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of...
- 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.
You likely can't join if
- Allergy to the main components or excipients of MDI-1228\_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or...
- 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.
See the full eligibility criteria
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. 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.