None listed
Conditions
Brief summary
This study will examine the effect of wound debridement frequency on the healing of foot ulcers in people with diabetes. The study will take place in up to 2 different sites, the Diabetes Centre High Risk Foot Service at Royal Prince Alfred Hospital (RPAH) and the High Risk Foot Service at Concord General Repatriation Hospital (CGRH). Foot ulcers most often develop because diabetes can cause damage to the nerves and/or blood vessels of the feet. An important part of treatment is a procedure called debridement. This is when the Podiatrist or the Nurse removes hard skin from the edge of the ulcer and unhealthy tissue, called slough or necrotic tissue, from the base of the ulcer. This is done using a scalpel blade and/or curette and/or forceps; each are special instruments to help to remove unhealthy tissue. While debridement is considered best practice and is performed safely and with good effect on wound healing, and is part of the standard care patients recieve at this service, there is very limited evidence to tell us how often this should be done and whether the frequency with which it is done affects how the ulcer heals. The purpose of this study is therefore to look at whether debridement performed on a weekly basis versus every 2 weeks affects the healing of diabetes-related foot ulcers. As of April 2018, there are 5 participating treatment sites; Concord, Royal Prince Alfred Hospital, St George Hospital, John Hunter and Bankstown Hospitals. Northern Sydney Hospitals, Royal North Shore and Hornsby have submitted site specific approval to become additional sites for this study.
Interventions
• Standard assessment (including grading) and treatment is documented in an evidence-based clinical treatment guideline (unpublished) which was written by the lead site in consultation with a multidisciplinary expert group. Participating sites agreed to the standard treatment protocol.
• Standard treatment is also defined partly by the model of care whereby the patient is treated in a public health facility with access to review by a medical practitioner and access to referral for radiological s
• Standard assessment (including grading) and treatment is documented in an evidence-based clinical treatment guideline (unpublished) which was written by the lead site in consultation with a multidisciplinary expert group. Participating sites agreed to the standard treatment protocol. • Standard treatment is also defined partly by the model of care whereby the patient is treated in a public health facility with access to review by a medical practitioner and access to referral for radiological scans, pathology requests, antibiotics and diabetes management as needed. • Conservative Sharp Wound Debridement practice is standardised by the definition that it removes callus from the wound edge and necrotic tissue from the base of the wound using scalpel, forceps and curettes. Images of foot ulcers before and after debridement are circulated within the participating sites to allow the podiatrists to visualise the extent of debridement. While the time taken to debride is not controlled, we anticipate the time taken to remove callus, slough and non-viable tissue using a scalpel, forceps and curette is 10-15 minutes each time. • Pressure offloading is standardised to use of a removable cast walker and/or all-purpose healing sandal, both of which are fitted with a custom moulded plastazote orthosis or an OAPL Brand Diabetic Insole comprised of plastazote and foam of similar thickness and performance. Patient adherence (as self reported) is captured. • Wound care dressings are standardised only with regards to the standard practice of using non-adherant foam dressings or more absorbant dressings based on clinician decision. Podiatrists are encouraged not to use dressings where the explicit intention of the dressing is to debride. For example hypergel. Wound care recommendations are documented in the clinical treatment protocol. The use of antimicrobial dressings is documented but not controlled. No biological dressings or negative pressure therapy is to be used during the study period. The intervention is to debride the wound either weekly or second weekly (fortnightly) dependent on the allocation (by randomisation)
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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,
Exclusion criteria
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
Outcome results
None listed