Evaluating a new gel treatment for diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and efficacy of MDI-1228-mesylate Gel in comparison to standard care for patients with diabetic foot ulcers. Approximately sixty participants will be enrolled and randomized to receive either the gel plus standard care or standard care alone. The primary outcome will be the complete healing rate of the target ulcer after 12 weeks, along with the reduction in ulcer area. The study will include a screening period, treatment phase, and follow-up to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion 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).

Exclusion Criteria:

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.

Where it's running

• Site 001
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Amanda Fu, M.D.,MBA
• Email: amanda.fu@d2vclinical.com
• Phone: 3910204908

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BIOxHEAL plus standard care for nonhealing diabetic foot ulcers

  A multicenter study tests whether applying BIOxHEAL, a placental-derived biologic, to stubborn diabetic foot ulcers helps more people heal when added to standard wound care.

  Recruiting Phase 3 Applied Biologics, LLC · Boardman, Ohio · NCT07852338

• Calcaneal Bone Marrow Cells in Foot/Ankle Surgery Patients

  This observational study tests whether routine preoperative blood tests relate to the quality and behavior of mesenchymal stem cells from calcaneal bone marrow in adults undergoing foot or ankle surgery.

  Recruiting Universidade Sao Francisco · Bragança Paulista, São Paulo · NCT07802106

• L-Carnitine as an add-on for healing diabetic foot ulcers

  This study tests whether taking L-Carnitine helps wound healing in adults with diabetic foot ulcers, alongside standard diabetes and wound care.

  Recruiting Phase 2 Ain Shams University · Cairo, Cairo Governorate and 1 other locations · NCT07768228

• THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers

  This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.

  Recruiting Biointelligent Technology Systems SL · Barcelona · NCT07617961

• Pulsating electromagnetic field therapy for diabetic foot ulcers

  This trial tests whether a PEMF device called CRAD ULCER X-01 helps heal chronic diabetic foot ulcers when added to standard wound care.

  Recruiting National Defence University of Malaysia · Kuala Lumpur · NCT07465640

• Transverse tibial bone transport to help heal chronic diabetic foot ulcers

  This study tests a surgical approach called transverse tibial bone transport to see if it can help heal long‑lasting diabetic foot ulcers and prevent limb loss in adults with limited treatment options.

  Recruiting Biodynamik, Inc · Jacksonville, Florida · NCT07444593

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.