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Trial registered on ANZCTR


Registration number
ACTRN12618000703202
Ethics application status
Approved
Date submitted
25/02/2015
Date registered
30/04/2018
Date last updated
19/05/2020
Date data sharing statement initially provided
19/05/2020
Date results information initially provided
19/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial Addressing Wound Debridement Frequency and Healing Outcomes in Diabetic Foot Ulcers
Scientific title
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.
Secondary ID [1] 286203 0
Translational Research Grant Scheme Project # 96
Universal Trial Number (UTN)
U1111-1167-6278
Trial acronym
Diabetes Debridement Study (DDS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic foot ulceration 294302 0
Condition category
Condition code
Skin 294624 294624 0 0
Other skin conditions
Public Health 306607 306607 0 0
Health service research
Metabolic and Endocrine 306608 306608 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Standard assessment (including grading) and treatment is documented in an evidence-based clinical treatment guideline (unpublished) which was written by the lead site in consultation with a multidisciplinary expert group.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)
Intervention code [1] 291264 0
Treatment: Other
Comparator / control treatment
The frequencies of debridement (weekly versus every second week) are compared.
Control group
Active

Outcomes
Primary outcome [1] 294389 0
The primary end-point of this Randomised Controlled Trial is to determine the effect of sharp wound debridement (SWD) performed at weekly versus second weekly intervals, on the healing of diabetes-related foot ulcers (DRFU).
Percentage of diabetes-related foot ulcers (DRFU) healed by 12 weeks.
Healing is defined by complete wound closure without exudate and is documented at the first treatment visit where this occurs. The wound is also photographed at baseline, 4 and 12 weeks and acetate outlines of the wound are performed. A blinded assessor will be used to verify wound healing based on photographs.
Timepoint [1] 294389 0
The primary endpoint is assessed at Week 12 of the study which is 12 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.
Secondary outcome [1] 313178 0
a) % reduction from baseline in ulcer area by 4 and 12 weeks using a calculation of the wound size as determined by wound outlines recorded on clear acetate and placed over a grid of known size.
Timepoint [1] 313178 0
Week 12 of the study which is 12 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.
Week 4 of the study which is 4 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.
Secondary outcome [2] 313179 0
b) rate of change from baseline in proteinases and reparative cytokines in wound fluid (on a subset of patients
Timepoint [2] 313179 0
Week 12 of the study which is 12 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.
Week 4 of the study which is 4 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.
Week 2 is 2 weeks after the baseline visit (week 0)
Secondary outcome [3] 313180 0
c) frequency of clinical bacterial infection in the ulcer
Treating podiatrists assess and grade the severity of infection at each patient visit and this is recorded. Infection is diagnosed and graded according to clinical assessment according to the Infectious Disease Society America guidelines. This is included in the clinical treatment protocol used in the study.
Timepoint [3] 313180 0
Week 12 of the study which is 12 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.
Week 4 of the study which is 4 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.
Secondary outcome [4] 313181 0
d) frequency of hospitalisation is recorded in the medical record and this data is provided by the site investigators
Timepoint [4] 313181 0
Week 12 of the study which is 12 weeks after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement
Secondary outcome [5] 313182 0
e) frequency and level of any amputation
Amputation outcome will be recorded for all patients during the study period by the treating podiatrist in the medical record. At 6 months following completion of the study, each patient will be contacted by phone or in person or by examining the medical records to determine outcomes of this cohort at 6 months.
Timepoint [5] 313182 0
6 months is 6 months after the baseline visit (week 0) when patients are allocated to weekly or second weekly (fortnightly) debridement.

Eligibility
Key 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,
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At the time of submission, subjects were randomised using a computer generated sequence.
The randomisation process is currently managed externally by the NHMRC Clinical Trial Centre, Sydney University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The primary outcome will be assessed by independent assessors, blinded to treatment allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2015
Date of last participant enrolment
Anticipated
1/08/2018
Actual
23/09/2019
Date of last data collection
Anticipated
Actual
27/12/2019
Sample size
Target
120
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3510 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 3511 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 10771 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [4] 10772 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 10773 0
St George Hospital - Kogarah
Recruitment hospital [6] 16706 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 16707 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 16708 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 9275 0
2050 - Camperdown
Recruitment postcode(s) [2] 9276 0
2137 - Concord
Recruitment postcode(s) [3] 22509 0
2200 - Bankstown
Recruitment postcode(s) [4] 22510 0
2305 - New Lambton
Recruitment postcode(s) [5] 22511 0
2217 - Kogarah
Recruitment postcode(s) [6] 30307 0
2065 - St Leonards
Recruitment postcode(s) [7] 30308 0
2077 - Hornsby
Recruitment postcode(s) [8] 30309 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 290810 0
Hospital
Name [1] 290810 0
Royal Prince Alfred Hospital
Country [1] 290810 0
Australia
Funding source category [2] 299287 0
Government body
Name [2] 299287 0
Ministry of Health
Country [2] 299287 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
c/o Diabetes Centre RPAH
Level 6 West
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 298571 0
Government body
Name [1] 298571 0
Ministry of Health, NSW. Office for Health and Medical Research
Address [1] 298571 0
Office for Health and Medical Research
Ministry of Health
Level 5, 73 Miller Street
North Sydney, NSW 2060
Country [1] 298571 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292436 0
SLHD Research Ethics and Governance Office
Ethics committee address [1] 292436 0
Research Ethics and Governance Office (REGO) Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 292436 0
Australia
Date submitted for ethics approval [1] 292436 0
01/03/2015
Approval date [1] 292436 0
05/05/2015
Ethics approval number [1] 292436 0
x14-0184&HREC/14/RPAH/242

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Newsletters regarding the progress of this study may be requested by emailing the CI or research co-ordinator at [email protected]

Contacts
Principal investigator
Name 55050 0
Ms Vanessa Nube
Address 55050 0
C/- Diabetes Centre
High Risk Foot Service
Royal Prince Alfred Hospital
Missenden Road
Camperdown
Sydney, NSW 2050
Country 55050 0
Australia
Phone 55050 0
+61 0297675221
Fax 55050 0
61 02 97675297
Email 55050 0
[email protected]
Contact person for public queries
Name 55051 0
Ms Jessica White
Address 55051 0
C/- Diabetes Centre
High Risk Foot Service
Royal Prince Alfred Hospital
Missenden Road
Camperdown
Sydney, NSW 2050
Country 55051 0
Australia
Phone 55051 0
+61 (02) 97675221
Fax 55051 0
+61 (02) 97675297
Email 55051 0
[email protected]
Contact person for scientific queries
Name 55052 0
Ms Vanessa Nube
Address 55052 0
C/- Diabetes Centre
High Risk Foot Service
Royal Prince Alfred Hospital
Missenden Road
Camperdown
Sydney, NSW 2050
Country 55052 0
Australia
Phone 55052 0
+61 02 97675221
Fax 55052 0
+61 (02) 97675297
Email 55052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not yet sought ethics committee approval for data sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4511Study results articleYes 21st October 2021 Published online ahead of print ... [More Details] 367998-(Uploaded-14-12-2021-14-39-29)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.