Diabetic Foot UlcerPhase 2DFUNCT06852976
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
A Phase 2 study of Diabetic Foot Ulcer, run by Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2025to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Site 001
Durham, North Carolina, 27703
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- 0.75% MDI-1228_mesylate gel plus Standard of Care, Standard of Care Alone
- Keywords
- Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% MDI-1228_mesylate gel plus Standard of CareDrug
Also called MDI-1228
Approximately 40 subjects will receive 0.75% MDI-1228_mesylate gel twice daily for 12 weeks.
Standard of Care AloneOther
Also called Standard of Care
Approximately 20 subjects will receive the standard of care alone including wound cleaning, debribement and other additional care decided by the healthcare provider.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Standard of Care for Diabetic Foot Ulcer Receives: Other: Standard of Care Alone |
| Treatment Arm | Experimental | MDI-1228-mesylate Gel plus Standard of Care Receives: Drug: 0.75% MDI-1228_mesylate gel plus Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug related treatment emergent adverse events
Incidence (severity and causality) of any drug related local and systemic treatment emergent adverse events （TEAE） for 12 weeks during the study treatment.
Measured: 1-12 weeks
Complete Healing and Time to closure for targeted diabetic foot ulcer
The proportion of subjects with complete healing of the target ulcer area after 12 weeks of treatment
Measured: 1-12 weeks
Secondary outcomes (1)
Ulcer area reduced by 50%
The proportion of subjects whose ulcer area was reduced by 50% after 12 weeks of treatment. [The ulcer area will be calculated using a photograph of the ulcer area and PI assessment.]
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start12 Mar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852976
- Sponsor's protocol ID
- RPT-1228-101
- Acronym
- DFU
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- DFU / RPT-1228-101
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Standard of Care AloneStandard of Care for Diabetic Foot Ulcer |
| Treatment Arm | Experimental | Drug: 0.75% MDI-1228_mesylate gel plus Standard of CareMDI-1228-mesylate Gel plus Standard of Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.75% MDI-1228_mesylate gel plus Standard of CareAlso: MDI-1228Approximately 40 subjects will receive 0.75% MDI-1228_mesylate gel twice daily for 12 weeks. | Drug | Treatment Arm |
| Standard of Care AloneAlso: Standard of CareApproximately 20 subjects will receive the standard of care alone including wound cleaning, debribement and other additional care decided by the healthcare provider. | Other | Control Arm |
Primary outcome
Drug related treatment emergent adverse events
Time frame: 1-12 weeks
Incidence (severity and causality) of any drug related local and systemic treatment emergent adverse events （TEAE） for 12 weeks during the study treatment.
Complete Healing and Time to closure for targeted diabetic foot ulcer
Time frame: 1-12 weeks
The proportion of subjects with complete healing of the target ulcer area after 12 weeks of treatment
1 secondary outcome
Ulcer area reduced by 50%
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Diabetic Foot Ulcer, run by Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Fu, M.D.,MBA (3910204908, amanda.fu@d2vclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug related treatment emergent adverse events (time frame: 1-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.