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 sites121 target enrollmentApril 30, 2018

Overview

No summary available.

Registry

who.int

Start Date

April 30, 2018

End Date

December 27, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

•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