Randomised Controlled Trial Addressing Wound Debridement Frequency and Healing Outcomes in Diabetic Foot Ulcers
- Conditions
- Diabetic foot ulcerationSkin - Other skin conditionsPublic Health - Health service researchMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12618000703202
- Lead Sponsor
- Royal Prince Alfred Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 121
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method