OptiPulse™ for Diabetic Foot Ulcers

Recruiting at29 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: DBC Medical, Inc.

Must not be taking: Immune-suppressants, Cytotoxic chemotherapy

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

No Placebo Group

Trial Summary

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. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

I am willing to use birth control and take pregnancy tests during the study.

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.

Trial Timeline

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

Treatment Details

Interventions

• OptiPulse™ (Vascular Therapy Device)
• PulseFlowDF™ (Vascular Therapy Device)
• Standard of Care offloading device (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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

1997 William J. Stickel Bronze Award. Comparison of strategies for reducing pressure at the site of neuropathic ulcers. [2007]

3. Germany pubmed.ncbi.nlm.nih.gov

[Quality control and quality assurance in therapeutic shoes for the diabetic foot]. [2006]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A review of the Eurodiale studies: what lessons for diabetic foot care? [2021]