Evaluating the Effectiveness of EmoLED Photobiomodulation Therapy as an Adjunct to Standard of Care in the Management of Venous Leg Ulcers and Non-healing Leg Ulcers, The EEEP Randomised Controlled Trial

Vascular One0 个研究点目标入组 148 人开始时间: 2026年7月20日最近更新: 2026年7月13日

适应症

试验速览

暂无简介。

•for the study:
•Presence of chronic lower leg venous ulcer (Greater than or equal to 6 weeks duration) with a surface area of less than or equal to 80cm2
•Presence of chronic lower leg non-venous ulcer associated with oedema or immobility (Greater than or equal to 6 weeks duration) with a surface area of less than or equal to 80cm2
•Ulcer is not circumferential
•Able to attend the required number of clinic visits for wound dressings
•Can provide written informed consent and complete questionnaires or informed consent and questionnaires can be completed by the legal person responsible
•As the maximum diameter of the EmoLED treatment beam is 5cm (surface area of 19.6cm2) and chronic ulcers require 120 seconds irradiation per application, the maximum ulcer surface area that can be included is 80cm2, equal to a maximum of four consecutive applications (a total of 8 minutes).

•for the study:
•Wound present for less than 6 weeks
•Wound greater than 80cm2
•Circumferential ulcers
•Malignant ulcers
•Arterial ulcers with Toe Brachial Index (TBI) less than 0.5 or Ankle Brachial Pressure Index (ABPI) less than 0.6
•Pressure ulcers
•Use of other advanced therapies such as Negative Pressure Wound Therapy (NPWT), grafting, topical oxygen therapy
•Presence of untreated osteomyelitis, spreading or systemic infection
•Previous treatment with photo biomodulation therapy
•Pregnancy or breastfeeding
•Unable to provide informed consent or complete questionnaires
•The ulcer cannot be circumferential as the ulcer needs to be photographed to measure the wound using the Wound Genius phone application (imito AG, Zurich Switzerland).

发起方

Vascular One