Diabetes Debridement Study (DDS)A Randomised Controlled Trial to determine the effect of sharp wound debridement performed at weekly versus second weekly intervals, on the percentage of diabetes-related foot ulcers (DRFU) healed by 12 weeks.

Royal Prince Alfred Hospital0 个研究点目标入组 121 人开始时间: 2018年4月30日最近更新: 2020年5月25日

试验速览

暂无简介。

•Type 1 or Type 2 Diabetes
•Aged between 18 and 85 years
•Able to ambulate at least short distances such as to perform activities of daily living
•Any presentation of neuropathic or neuro-ischaemic foot Ulceration of at least 2 weeks duration
•With an area equal to or greater than 0.5cm2 and equal or less than 10cm2 on the plantar aspect of either foot
•If there is more than 1 ulcer on either foot, the ulcer with the largest area will be randomised and included in the study.
•Infection must be considered clinically controlled as per the PEDIS wound classification system, of grade 1 or 2,

•Severe peripheral arterial disease (PAD) in the foot affected by ulceration.
•This is indicated by either;:
•-impalpable pedal pulses and ankle brachial pressure index (ABPI) <0.6 or
•-toe pressure index (TBPI) < 40mmHg
•-monophasic waveforms if ABPI or TBPI unobtainable
•Clinical signs of infection grade 3 or above or with osteomyelitis by the PEDIS infection classification system at baseline
•Acute or subacute Charcot Arthropathy associated with the foot ulcer
•Inability to give informed consent
•Inability to attend weekly appointments
•Foot ulcer which has been managed by the recruiting High Risk Foot Service for >6 months
•Foot ulcer which is located in an area of no pressure/non-weight-bearing

发起方