OptiPulse™ for Diabetic Foot Ulcers

Recruiting at 29 trial locations

Overseen By Daniel Blackman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DBC Medical, Inc.

Must not be taking: Immune-suppressants, Cytotoxic chemotherapy

Disqualifiers: HIV, Hepatitis C, Poor metabolic control, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called OptiPulse™ to determine if it can heal diabetic foot ulcers more effectively than current methods. OptiPulse™ is a specialized type of footwear designed to enhance blood flow to the feet. The trial compares this footwear to the usual care for diabetic foot ulcers. Individuals who have had a diabetic foot ulcer for more than four weeks but less than a year, and who meet certain other health criteria, might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could improve quality of life.

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 prior data suggests that OptiPulse™ is safe for treating diabetic foot ulcers?

Research has shown that OptiPulse™ is generally safe. One study found no serious side effects or problems linked to the device, indicating that participants did not face major safety issues from using OptiPulse™. The device aids in improving blood flow, which is crucial for healing diabetic foot ulcers. With FDA approval for its intended use, OptiPulse™ has met certain safety standards. However, individuals should consider their own health and consult their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for diabetic foot ulcers, which often involve just offloading devices like CAM boots to reduce pressure on the foot, OptiPulse™ takes a more active approach. This treatment is designed to enhance blood circulation in the small blood vessels of the lower extremities, potentially speeding up healing. OptiPulse™ is unique because it combines a shin pumping unit with pressure-reducing footwear, offering a balanced gait while promoting blood flow. Researchers are excited about the potential of OptiPulse™ to address the root issue of poor circulation, offering a novel method that might improve healing outcomes for patients.

What evidence suggests that OptiPulse™ is effective for diabetic foot ulcers?

Research has shown that OptiPulse™, one of the treatments under study in this trial, may aid in treating diabetic foot ulcers by improving blood flow in small blood vessels. One study found that patients with infected diabetic foot ulcers healed faster when using OptiPulse™. This treatment aims to boost blood flow, which is crucial for wound healing. Another report indicates that OptiPulse™ is safe and effective for managing these ulcers. This evidence suggests that OptiPulse™ could be a valuable option for healing diabetic foot ulcers. Participants in this trial may receive either OptiPulse™ or a standard of care offloading device for comparison. ^{1 2 3 5 6}

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

Subject understands and is willing to participate in the clinical study and can comply with weekly visits

My ulcer has been properly rested for over 2 weeks.

Subjects must have read and signed the IRB approved ICF before screening procedures are performed

Exclusion Criteria

My wound is openly infected with pus.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the OptiPulse™ device or standard of care for diabetic foot ulcers

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OptiPulse™
• PulseFlowDF™
• Standard of Care offloading device

Trial Overview

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.

How Is the Trial Designed?

Group I: OptiPulse™ Experimental Treatment 1 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 device Active Control 1 Intervention

Diabetic CAM boot

Who Is Running the Clinical Trial?

DBC Medical, Inc.

Lead Sponsor

Trials

1

Recruited

100+

Compedica Inc

Lead Sponsor

Trials

1

Recruited

100+

Professional Education and Research Institute

Collaborator

Trials

16

Recruited

1,400+

Published Research Related to This Trial

Diabetic foot ulcers are serious conditions that can lead to severe complications like infection and amputation, highlighting the need for effective treatment strategies.

Despite the availability of numerous treatment options, many are based on outdated practices and anecdotal evidence, indicating a need for more evidence-based approaches to improve patient outcomes and reduce the risk of amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic foot ulcers: current treatment options and new developments. Bell, DP.[2010]

In a study involving 32 midgait steps, removable walking casts were found to be as effective or even more effective than total contact casts in reducing peak plantar foot pressures at neuropathic ulcer sites in diabetic patients.

Half-shoes were the third most effective option, while accommodative dressings and rigid-soled postoperative shoes were less effective in alleviating pressure at ulcer sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1997 William J. Stickel Bronze Award. Comparison of strategies for reducing pressure at the site of neuropathic ulcers. Fleischli, JG., Lavery, LA., Vela, SA., et al.[2007]

The Eurodiale study, which included 1232 diabetic patients with foot ulcers across 14 European centers, revealed significant variations in the quality of care provided, indicating a need for standardized treatment protocols.

This large multicenter study highlighted the complexities of managing diabetic foot ulcers and emphasized the importance of improving care strategies to reduce complications and healthcare costs associated with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the Eurodiale studies: what lessons for diabetic foot care? Akhtar, S., Schaper, N., Apelqvist, J., et al.[2021]

Custom-made cushioned footwear can reduce the risk of ulcer relapses in diabetic patients by approximately 50%, based on observations from 217 patients across various centers.

There is a need for more precise and standardized long-term studies to evaluate the effectiveness of such footwear, including better monitoring of foot pressure during walking to ensure quality control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality control and quality assurance in therapeutic shoes for the diabetic foot]. Chantelau, E., Jung, V.[2006]

A feasibility study involving 61 participants with diabetic peripheral neuropathy tested an optimised insole against a standard cushioned insole, showing a reduction in mean peak plantar pressure (MPPP) favoring the optimised insole.

While there were incidences of foot ulceration in both groups, the results suggest that the optimised insole may be a promising intervention, warranting further research into its clinical and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study. Collings, R., Freeman, J., Latour, JM., et al.[2023]

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Study Details | NCT05193929 | A Clinical Investigation ...

The OptiPulse™ is designed to enhance blood circulation in the venules and arterioles in subjects with diabetic foot ulcers of the lower extremities. OptiPulse™ ...

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pmc.ncbi.nlm.nih.gov/articles/PMC9927907/

A single arm prospective feasibility study evaluating wound ...

In a study conducted by Armstrong and Nguyen, a higher proportion of healing was noted in patients with infected diabetic foot ulcers who ...

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Compedica Publishes Positive Results in a Single Arm ...

Compedica Publishes Positive Results in a Single Arm Prospective Feasibility Study Evaluating the Safety and Efficacy of OptiPulse™ active therapy system in ...

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withpower.com/trial/phase-diabetic-foot-11-2021-c7985

OptiPulse™ for Diabetic Foot Ulcers

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 ...

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frontiersin.org/journals/clinical-diabetes-and-healthcare/articles/10.3389/fcdhc.2023.1212182/epub

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Current Studies | Medical Trials Los Angeles

This clinical investigation aims to assess the safety and performance of Compedica's OptiPulse™ (also known as PulseFlowDF™). Also, to collect subject ...