Original Article
Evaluation of the clinical utility, efficacy and safety of a novel medical device for the treatment of foot ulcers: Rationale and design of the carbothera trial
Author(s): Paramjit S. Tappia*, Grant N. Pierce, Bram Ramjiawan, Hiroaki Hasebe and Hideo Kumamoto
BACKGROUND: Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with peripheral arterial disease, diabetes and kidney disease. OBJECTIVE: To evaluate the healing potential of CO2-enriched water in patients with foot ulceration. METHODS: This is a multi-centered; placebo controlled and randomized clinical trial. Patients will have at least 1 distal extremity ulcer and will be randomized to receive a treatment with bath therapy at 37ºC containing either 1,000-1200 ppm CO2-enriched tap water (the intervention), or non- carbonated tap water (the control group). The treatment will be carried out 3 times/week for 15 minutes per session for 4 months for a total of 48 treatments. At baseline and at the end of every treatmen.. Read More»
DOI:
10.4172/2368-0512.1000076
