Effectiveness of Home Use Photobiomodulation Therapy as an Adjunct to Standard Care for the Treatment of Lower Limb Ulcers in Diabetic Patients with Skin Types V and VI

Prof Nicolette Houreld0 个研究点目标入组 60 人开始时间: 2021年6月21日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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).

•Pre-existing conditions- evidence of gangrene on any part of affected limb, infection at screening, deep
•vein thrombosis (DVT), active malignancy, anaemia (Hb<9 gr/dL).
•Known allergies to dressing materials, including occlusive dressings and the adhesive on such dressings.
•Scheduled to undergo vascular surgery, angioplasty, or thrombolysis at the time of screening or history of
•peripheral vascular repair within 4 weeks of screening.
•History of malignancy in study limb or currently receiving or has received radiation or chemotherapy within
•3 months of randomization.
•Taking immunosuppressive medication.
•Received growth factor therapy within 2 weeks of screening.
•Has an HbA1c level of > 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.

发起方

Prof Nicolette Houreld