Nutritional, Metabolic, Endocrine
Conditions
Interventions
B Cure laser pro
Sponsors
Prof Nicolette Houreld
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female. • Fitzpatrick skin type V-VI. • Type I or Type II DM. • Age: 18-90 years old. • Presence of a DFU located on the ankle area or below that has persisted a minimum of 4 weeks prior to the initial screening visit. • Ulcer grade classified as < IIIA according to the University of Texas Classification of Diabetic foot ulcers (Lavery et al., 1996). • Area of ulcer (after debridement) is at least 2 cm2. • Patients who demonstrate adequate arterial perfusion defined as either: Ankle-brachial index (ABI) above 0.7 or that have documented confirmation of adequate arterial perfusion. • State willingness to comply with all the procedures and availability for the duration of the study. • Patients and/or caregivers must be able and willing to learn and perform the duties of dressing changes. • Provision of signed and dated informed consent form. • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation (safe use of photobiomodulation or low level laser therapy during pregnancy has not been established).
Exclusion criteria
Exclusion criteria: • Pre-existing conditions- evidence of gangrene on any part of affected limb, infection at screening, deep vein thrombosis (DVT), active malignancy, anaemia (Hb 12% (indication of uncontrolled DM). • Has serum albumin level of <3 g/dL (indication of malnutrition). • Documented history of alcohol or substance abuse within 6 months of screening. • Currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results. • Pregnant at time of screening. • Has any PBM device at home.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the B-cure laser pro as an adjuvant to standard treatment (experimental group) compared to sham-control with standard treatment (control group) for healing diabetic foot ulcers in patients with skin types V and VI. The primary endpoint is the incidence of complete (100%) wound closure defined as complete re-epithelialization without drainage. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the rate of diabetic foot ulcer complete wound closure between groups. The secondary endpoint is the time to 100% wound closure. ;To compare the rate of diabetic foot ulcer wound closure between groups. The endpoint is the time to 50%, 75% and 90% wound closure. ;To determine the effect of treatment on quality of life of patients with diabetic foot ulcers. The endpoint is the Quality of Life improvement from day 0 to week 12 or closure using the Diabetic Foot Ulcer Scale - Short Form. ;To determine subjective satisfaction with the treatment procedure. Subjective satisfaction based on a 5-point Likert scale [very dissatisfied to very satisfied]. ;To evaluate the long-term effectiveness of the B-cure treatment. The endpoint is the change in wound size from wound closure or 12 weeks ;To evaluate the effect of the treatment on tissue composition using digital photography. Changes in tissue composition from baseline as analyzed by the digital photography. ;To evaluate changes in thermal imaging of diabetic wounds. The endpoint is the change in wound thermal imaging from baseline. ;To evaluate changes in nerve conduction. The endpoint is the change in pressure applied from baseline using the monofilament test. | — |
Countries
South Africa
Contacts
Public ContactNicolette Houreld
Professor Laser Research Centre University of Johannesburg
Outcome results
None listed