Diabetic Foot UlcerPhase 1/2NCT01493895
Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
A Phase 1/2 study testing standard hoem treatment and LLLT-808 B-cure laser machine in people with Diabetic Foot Ulcer, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- standard hoem treatment and LLLT-808 B-cure laser machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Meir Liebergall, Prof. contact
About this study
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- standard hoem treatment, LLLT-808 B-cure laser machine
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard hoem treatmentDevice
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.
LLLT-808 B-cure laser machineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| control group, | Active comparator | The control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser. Receives: Device: standard hoem treatment |
| study, LLLT-808 B-cure laser machine | Experimental | The study group will be treated with the LLLT-808 B-cure laser machine, emitting the 808nm laser beam together with a green indicator light. Receives: Device: LLLT-808 B-cure laser machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
safety will be evaluated by counting advese events in each group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493895
- Sponsor's protocol ID
- becure-CTIL-HMO
- Status last verified
- Mar 2013
- First submitted
- 15 Dec 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34052927
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
- ClinicalTrials.gov ID
- NCT01493895
- Acronym / sponsor ID
- becure-CTIL-HMO
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group, | Active comparator | Device: standard hoem treatmentThe 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 | Experimental | Device: LLLT-808 B-cure laser machineThe study group will be treated with the LLLT-808 B-cure laser machine, emitting the 808nm laser beam together with a green indicator light. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard hoem treatmentAll 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. | Device | control group, |
| LLLT-808 B-cure laser machineFrom 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. | Device | study, LLLT-808 B-cure laser machine |
Primary outcome
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.
1 secondary outcome
safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Derived from this study: PubMed 34052927Haze 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.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meir Liebergall, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing standard hoem treatment and LLLT-808 B-cure laser machine in people with Diabetic Foot Ulcer, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meir Liebergall, Prof. (972-2-6776342), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.