Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
Trial Snapshot
- Phase
- Phase 1
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 cm
- •Ages: 21 - 75
- •Gender: male and female
Exclusion Criteria
- •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
- •Presence of or known cancerous comorbidity.
Outcomes
Primary Outcomes
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
- safety