What side effects are associated with this type of intervention?

Common treatments for diabetic foot ulcers (DFUs) that enhance blood circulation, such as mechanical devices like OptiPulse™, generally aim to improve blood flow in the venules and arterioles. Known side effects of these treatments can include skin irritation, discomfort, or pain at the site of application. Collagen alginate dressings, often used in conjunction with these devices, may cause mild allergic reactions or local skin sensitivities. It is important to monitor for any adverse reactions and consult with a healthcare provider to ensure the treatment is appropriate and effective.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic foot ulcers (DFUs) that enhance blood circulation and promote healing. OptiPulse™ is one such device designed to improve blood flow in the venules and arterioles, aiding in the treatment of non-healing DFUs. Additionally, Fibracol Plus, a collagen alginate dressing, is FDA cleared and used to support wound healing by maintaining a moist environment and providing structural support. Both products are utilized within their intended use to manage and treat DFUs effectively.

What other types of research exist?

Promising alternatives to OptiPulse™ for foot ulcer treatment include: 1) Collagen-based dressings like Fibracol Plus, which promote healing by providing a scaffold for new tissue growth. 2) Negative pressure wound therapy (NPWT), which enhances blood flow and reduces edema. 3) Hyperbaric oxygen therapy (HBOT), which increases oxygen delivery to the wound site, promoting healing. 4) Advanced cellular and tissue-based products (CTPs) such as bioengineered skin substitutes that provide growth factors and extracellular matrix components to support wound healing.

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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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for diabetic foot ulcers (DFUs) focus on improving blood circulation, managing infection, and promoting wound healing. OptiPulse™ enhances blood circulation in the venules and arterioles, which is crucial for delivering oxygen and nutrients to the affected area, thereby accelerating healing. Collagen alginate dressings, like Fibracol Plus, provide a moist environment that supports tissue regeneration and absorbs exudate, reducing the risk of infection. These treatments are vital for DFU patients as they address the underlying issues of poor circulation and high infection risk, which are common complications in diabetes, ultimately improving healing outcomes and reducing the risk of severe complications such as amputation.

Dressings and topical agents for arterial leg ulcers.