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Vascular Therapy Device
OptiPulse™ for Diabetic Foot Ulcers
N/A
Recruiting
Research Sponsored by DBC Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks
Awards & highlights
Study Summary
This trial will compare the OptiPulse™ to the standard of care for treating diabetic foot ulcers.
Who is the study for?
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.Check my eligibility
What is being tested?
The study compares OptiPulse™ therapy—aiming to improve blood circulation in small vessels—with standard care using offloading devices for treating DFUs. Both interventions use an FDA-cleared collagen alginate dressing as part of treatment. The goal is to assess safety and effectiveness in wound closure.See study design
What are the potential side effects?
Potential side effects were not explicitly listed in the provided information; however, common side effects from similar wound treatments may include skin irritation around the treated area, infection risk if dressings aren't changed properly, and discomfort during application.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of index ulcers healed
Secondary outcome measures
Changes in wound quality of life from screening visit to end of study ( per W-QoL)
Percentage Area Change
Time to Ulcer Healing
Other outcome measures
Cost to Closure
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OptiPulse™Experimental Treatment1 Intervention
The OptiPulse™ is designed to enhance blood circulation in the venules and arterioles in subjects with diabetic foot ulcers of the lower extremities. OptiPulse™ is supplied as a pair of footwear. One side is fitted with an offloaded and shin pumping unit and the other acts as pressure reducing footwear. Both active and non-active footwear should be worn to give balanced gait.
Group II: Standard of care offloading deviceActive Control1 Intervention
Diabetic CAM boot
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Who is running the clinical trial?
DBC Medical, Inc.Lead Sponsor
Compedica IncLead Sponsor
Professional Education and Research InstituteOTHER
14 Previous Clinical Trials
1,068 Total Patients Enrolled
13 Trials studying Foot Ulcer
1,039 Patients Enrolled for Foot Ulcer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My ulcer has been properly rested for over 2 weeks.My wound is openly infected with pus.I am willing to use birth control and take pregnancy tests during the study.My wound is on the inner or outer side of my foot.My ulcer has shrunk by 30% or more in 14 days with standard care.My foot has good blood flow as shown by recent tests.I have a wound between my toes.My largest foot ulcer will be the focus if I have multiple with the same severity, and any others must be over 2 cm away.I have had radiation treatment at the site of my ulcer.My ulcer has not been treated with any therapies that are not allowed in this study.My ulcer is not caused by diabetes.You have been diagnosed with HIV or Hepatitis C in the past.My diabetes is not well-controlled, with an HbA1c over 12.0 in the last 3 months.My kidney function is severely impaired, with a creatinine level of 3.0 mg/dL or higher.I have active Charcot foot affecting one of my limbs.I am 18 years old or older.My ulcer has been present for more than 4 weeks but less than a year.I have a deep foot ulcer below my ankle.I haven't used strong immune-suppressants or chemotherapy for my condition in the last month.My doctor suspects my ulcer might be cancerous and recommends a biopsy.You have a bone infection in your foot confirmed by an x-ray within the last 30 days. If it's not clear, the main doctor will decide.The ulcer is between the size of a penny and the size of a tennis ball.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care offloading device
- Group 2: OptiPulse™
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrolment tally for this medical experiment?
"This trial necessitates 100 patients, who meet the set inclusion criteria. Those looking to sign up can do so at a variety of medical sites including Midland Florida Clinical Research Center LLC in DeLand, FL and Edward Jenner Research Group in Plantation NJ."
Answered by AI
Are there vacancies available for this research project?
"Affirmative. According to clinicaltrials.gov, this research has been open for recruitment since December 15th 2021 and is currently seeking 100 participants at 21 medical sites. Records show the trial was most recently updated on October 31st 2022."
Answered by AI
To what extent is this trial being conducted in medical centers?
"This clinical research has 21 recruiting sites, such as the Midland Florida Clinical Research Center LLC in DeLand, Edward Jenner Research Group in Plantation, and Inspira Medical Center Elmer."
Answered by AI
Who else is applying?
What site did they apply to?
Foot Associates of New York
What portion of applicants met pre-screening criteria?
Met criteria
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