OptiPulse™ for Diabetic Foot Ulcers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of OptiPulse™, a device that improves blood flow, in treating diabetic foot ulcers. It aims to see if this device helps heal these ulcers better than standard treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immune-suppressants, systemic corticosteroids over 10mg daily, cytotoxic chemotherapy, or topical steroids on the ulcer, you may not be eligible to participate.
What data supports the effectiveness of the treatment OptiPulse™ for Diabetic Foot Ulcers?
Research shows that therapeutic footwear and insoles can help reduce foot pressure, which is important for preventing diabetic foot ulcers. Additionally, removable walking casts have been found to effectively reduce foot pressures at ulcer sites, which may support the use of similar offloading devices in the treatment.12345
Are You a Good Fit for This Trial?
This trial is for adults with diabetic foot ulcers (DFUs) that are Wagner Grade 1, have been present for more than 4 weeks but less than a year, and measure between 0.8 cm2 to 25 cm2. Participants must have good blood flow to the affected foot and be able to attend weekly visits. Pregnant or breastfeeding individuals, those with poor diabetes control (HbA1c >12), severe kidney disease, certain infections like HIV or Hepatitis C, or who've had specific treatments at the ulcer site are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the OptiPulse™ device or standard of care for diabetic foot ulcers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OptiPulse™
- PulseFlowDF™
- Standard of Care offloading device
Find a Clinic Near You
Who Is Running the Clinical Trial?
DBC Medical, Inc.
Lead Sponsor
Compedica Inc
Lead Sponsor
Professional Education and Research Institute
Collaborator