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Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds

This study is not yet open for participant recruitment.
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01493895
First received: December 15, 2011
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcer
 Device: standard hoem treatment
Device: LLLT-808 B-cure laser machine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers [ Designated as safety issue: No ]
    the efficacy will be assesed using measurement of wound depth.


Secondary Outcome Measures:
  • safety [ Designated as safety issue: Yes ]
    safety will be evaluated by counting advese events in each group.


Arms Assigned Interventions
Active Comparator: control group,
The control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser.
 Device: standard hoem treatment

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.
Experimental: study, LLLT-808 B-cure laser machine
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.
 Device: LLLT-808 B-cure laser machine

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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Known Diabetes mellitus
  2. With an active chronic wound in the foot, that has been treated conventionally for over 3 months.
  3. No known osteomyelitis.
  4. Size of wound: 1-8 cm2.
  5. Ages: 21 - 75
  6. Gender: male and female

Exclusion Criteria:

  1. Signs of osteomyelitis.
  2. The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.
  3. There is active osteomyelitis in the bone underlying the ulcer.
  4. Pregnant women.
  5. Children under 21.
  6. Presence of or known cancerous comorbidity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493895

Contacts
Contact: Meir Liebergall, Prof. 972-2-6776342

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01493895     History of Changes
Other Study ID Numbers: becure-CTIL-HMO
Study First Received: December 15, 2011
Last Updated: March 21, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 23, 2013