Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
1 other identifier
interventional
N/A
1 country
1
Brief Summary
For centuries, light has been a well-known and effective healing method. In the beginning of the 20th century there was a first attempt to condense light energy and distribute it in higher levels, a use that was successfully applied on many soldiers wounded in the Second World War. The laser, which is based on the quantum phenomenon of stimulated emission, was first demonstrated in the beginning of the 1960s and immediately received many applications in all areas of medicine.Many different studies were carried out in the past decade trying to assess the effect of laser therapy on properties of healing wounds. This study aim to assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing diabetic foot ulcers.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedMarch 22, 2013
March 1, 2013
December 15, 2011
March 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers
the efficacy will be assesed using measurement of wound depth.
Secondary Outcomes (1)
safety
Study Arms (2)
control group,
ACTIVE COMPARATORThe control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser.
study, LLLT-808 B-cure laser machine
EXPERIMENTALThe study group will be treated with the LLLT-808 B-cure laser machine, emitting the 808nm laser beam together with a green indicator light.
Interventions
All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care. Every treatment will consist of the following steps: A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water. Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method.
From the day of entering the study, ulcers will be treated twice daily regardless of the treatment that was used until then. All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care. Every treatment will consist of the following steps: A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water. Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method. The part of the laser machine from which the laser beam is radiating - the beam guard, will be cleaned with a disposable swab of 70% alcohol. The cleaning will be performed while the machine is pointing downwards.
Eligibility Criteria
You may qualify if:
- Known Diabetes mellitus
- With an active chronic wound in the foot, that has been treated conventionally for over 3 months.
- No known osteomyelitis.
- Size of wound: 1-8 cm2.
- Ages: 21 - 75
- Gender: male and female
You may not qualify if:
- Signs of osteomyelitis.
- The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.
- There is active osteomyelitis in the bone underlying the ulcer.
- Pregnant women.
- Children under 21.
- Presence of or known cancerous comorbidity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, Israel
Related Publications (1)
Haze A, Gavish L, Elishoov O, Shorka D, Tsohar T, Gellman YN, Liebergall M. Treatment of diabetic foot ulcers in a frail population with severe co-morbidities using at-home photobiomodulation laser therapy: a double-blind, randomized, sham-controlled pilot clinical study. Lasers Med Sci. 2022 Mar;37(2):919-928. doi: 10.1007/s10103-021-03335-9. Epub 2021 May 29.
PMID: 34052927DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 16, 2011
Last Updated
March 22, 2013
Record last verified: 2013-03