B-Cure Laser Pro for Diabetic Foot Ulcers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetic Foot UlcersB-Cure Laser Pro - Device
Eligibility
18 - 95
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a home-use low-level laser device is effective for accelerating healing of diabetic foot ulcers.

Eligible Conditions
  • Diabetic Foot Ulcers

Treatment Effectiveness

Effectiveness Progress

1 of 3

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TRIAL INTERVENTION
1
Nitric Oxide-Releasing Solution
2
TTAX01

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 3 months

Up to 3 months
Incidence of complete (100%) wound closure
Time to complete (100%) wound closure

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
TRIAL INTERVENTION
1
Nitric Oxide-Releasing Solution
3
TTAX01

Trial Design

2 Treatment Groups

B-Cure Laser Pro
1 of 2
Sham laser
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: B-Cure Laser Pro · Has Placebo Group · N/A

B-Cure Laser Pro
Device
Experimental Group · 1 Intervention: B-Cure Laser Pro · Intervention Types: Device
Sham laser
Device
ShamComparator Group · 1 Intervention: Sham laser · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months

Who is running the clinical trial?

Scarborough Rouge HospitalLead Sponsor
3 Previous Clinical Trials
788 Total Patients Enrolled
Rose Raizman, MSc, MScNPrincipal InvestigatorScarborough Health Network

Eligibility Criteria

Age 18 - 95 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who demonstrate adequate arterial perfusion defined as either: Ankle/brachial index (ABI) above 0.5 or that have documented confirmation of adequate arterial perfusion.
You are willing to comply with all study procedures and are available for the duration of the study.
You have type 1 or type 2 diabetes mellitus.
Presence of a diabetic foot ulcer located in the ankle area or below that has persisted a minimum of 3 months prior to the screening visit.
The ulcer is at least 2 cm2.
Patient and/or caregiver must be able and willing to learn and perform the duties of dressing changes.
References

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