Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000293864
Ethics application status
Approved
Date submitted
20/01/2021
Date registered
17/03/2021
Date last updated
27/08/2021
Date data sharing statement initially provided
17/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of Sorbact on diabetic foot ulcers with suspected biofilm infections.
Scientific title
The effects of Dialkylcarbamoyl chloride (DACC)-coated mesh dressings (Sorbact®) with and without hydrogel on local chronic biofilm infections in Diabetic Foot Ulcers: An in vivo proof of concept study
Secondary ID [1] 303229 0
Nil known
Universal Trial Number (UTN)
U1111-1264-0561
Trial acronym
DACC-Biofilm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcer 320378 0
Biofilm infections 320809 0
Condition category
Condition code
Metabolic and Endocrine 318281 318281 0 0
Diabetes
Skin 318630 318630 0 0
Other skin conditions
Infection 318631 318631 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be alternately allocation to receive either: Cohort 1: Standard of Care plus Dialkylcarbamoyl chloride (DACC)-coated mesh dressing or; Cohort 2: Standard of Care plus DACC-coated mesh dressing with hydrogel on their chronic non-healing diabetic foot ulcer.
At recruitment patients will have their ulcer dressed with sterile gauze for 2-3 days. After this, they will have the ulcer dressed with the allocated DACC dressing.

Standard of care is defined as: at minimum weekly treatment by a podiatrist performing appropriate wound bed preparation through conservative sharp debridement or curettage, wound cleansing with NaCl 0.9% and the use of non-adherant absorbent wound dressing. Appropriate offloading will be prescribed as removable cast walker, or post-operative shoe.

Participants will receive this dressing for two weeks. They will be required to attend two thirty minute appointment each week for review. This equates to five appointments in total. The treatment and dressing will be undertaken in a High Risk Foot Service located at a tertiary hospital by a podiatrist with at least 5 years experience treating diabetic foot ulcers.

At each appointment the participant will receive standard of care as described above. After the one off application of sterile gauze at recruitment for 2 days, the wound will be re-dressed every 2-3 days with a new DACC dressing, depending on exudate. Participants can attend community nursing if they require a third dressing change in a week.
Adherence to the dressing is monitored based on review of the electronic medical record, and examination of the dressing when the participant presents for their appointment.

At the end of the study period, participants can continue to have their wound dressed with DACC dressing, or return to a plain non-adherent dressing regime.
Intervention code [1] 319534 0
Treatment: Devices
Intervention code [2] 319780 0
Treatment: Other
Comparator / control treatment
Cohort 1: Standard of Care plus Dialkylcarbamoyl chloride (DACC)-coated mesh dressing for their chronic non-healing diabetic foot ulcer.
Control group
Active

Outcomes
Primary outcome [1] 326265 0
To determine if biofilms present in non-healing diabetic foot ulcers are physically attracted and adhere to DACC-coated mesh dressings through examination with scanning electron microscopy (SEM) imaging
Timepoint [1] 326265 0
A sample of the soiled dressing will be collected after the first application (2-3 days) of the dressing.
A sample of the soiled dressing will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [1] 390814 0
To assess the microbial load of diabetic foot ulcer tissue before and after therapy through 16S rRNA sequencing.
Timepoint [1] 390814 0
A wound swab will be collected after the first application (2-3 days) of the dressing.
A wound swab will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [2] 390815 0
Explore the bacterial diversity present in and on diabetic foot ulcer tissue before and after therapy through 16S rRNA sequencing.
Timepoint [2] 390815 0
A wound swab will be collected after the first application (2-3 days) of the dressing.
A wound swab will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [3] 392025 0
To assess the microbial load of a DACC-coated mesh dressing, before and after therapy with 16S rRNA sequencing.
Timepoint [3] 392025 0
A sample of the soiled dressing will be collected after the first application (2-3 days) of the dressing.
A sample of the soiled dressing will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [4] 392026 0
Explore the fungal diversity present in and on the DACC-coated mesh dressing before and after therapy through internal transcribe spacer 1 (ITS1) sequencing
Timepoint [4] 392026 0
A sample of the soiled dressing will be collected after the first application (2-3 days) of the dressing.
A sample of the soiled dressing will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [5] 392027 0
Explore the bacterial diversity present in and on the DACC-coated mesh dressing before and after therapy through 16S rRNA sequencing.
Timepoint [5] 392027 0
A sample of the soiled dressing will be collected after the first application (2-3 days) of the dressing.
A sample of the soiled dressing will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [6] 392028 0
Explore the fungal diversity present in and on diabetic foot ulcer tissue before and after therapy through internal transcribe spacer 1 (ITS1) sequencing
Timepoint [6] 392028 0
A wound swab will be collected after the first application (2-3 days) of the dressing.
A wound swab will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [7] 392029 0
Assess the spatial organization of microbial aggregates in tissue with Peptide nucleic acid fluorescent in situ hybridization (PNA-FISH)
Timepoint [7] 392029 0
A tissue sample will be collected after the first application (2-3 days) of the dressing.
A tissue sample will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).
Secondary outcome [8] 392030 0
Confirm the presence of biofilm within the wound with Scanning electron microscopy (SEM)
Timepoint [8] 392030 0
A tissue sample will be collected after the first application (2-3 days) of the dressing.
A tissue sample will be collected after the final application of the dressing at the end of the study period (2 weeks since starting intervention).

Eligibility
Key inclusion criteria
- Type one or two diabetes mellitus
- Non-healing diabetic foot ulcers (defined as non-healing for over six weeks, with a minimum of a 4 week run in period with no changes in wound surface area) with signs of biofilm infection (recalcitrance to treatment with antibiotics or antiseptics, treatment failure despite using antibiotics or antiseptics, delayed healing, cycles of recurrent infection, excessive moisture and wound exudate, low level chronic inflammation, low level erythema)
- Diabetic foot ulcers as graded by the Wound Ischemia foot Infection (WIfI) score as; Wound: Grade 1 and 2 (excluding exposed deep structures or bone involvement), Ischemia Grade 0-2, Infection grade 0
- Sensory neuropathy (neuropathy disability score over 6)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- New acute diabetic foot infection requiring new antibiotic regimen
- Current anticoagulation therapy such as Warfarin, Clopidogrel and INR over 2
- Currently being treatment for osteomyelitis
- Under 18 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sequence quality control and analysis will be performed using CLC genomic workbench with microbial genomics module addition.
Wound metrics and microbiome data will be analysed through SPSS. A Wilcoxian signed rank test for paired data will be used to determine the difference in Log10 before and after treatment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/02/2021
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
14/02/2022
Actual
Sample size
Target
20
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 18477 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 18752 0
Dandenong Hospital - Dandenong
Recruitment hospital [3] 18753 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 32795 0
2170 - Liverpool
Recruitment postcode(s) [2] 33196 0
3175 - Dandenong
Recruitment postcode(s) [3] 33197 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 307636 0
Commercial sector/Industry
Name [1] 307636 0
Abigo Medical AB
Country [1] 307636 0
Sweden
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Liverpool Hospital
75 Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 308321 0
Other
Name [1] 308321 0
South West Sydney Limb Preservation and Wound Research
Address [1] 308321 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool NSW 2170
Country [1] 308321 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307678 0
South Western Sydney Local Health District Ethics Committee
Ethics committee address [1] 307678 0
Research and Ethics Office
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 307678 0
Australia
Date submitted for ethics approval [1] 307678 0
13/10/2020
Approval date [1] 307678 0
25/11/2020
Ethics approval number [1] 307678 0
2020/ETH02721

Summary
Brief summary
Biofilms are a cause of localised chronic infection and have been demonstrated to be present in wounds. Biofilms are tolerant to many antimicrobial agents, antibiotics and the host immune system. There is limited evidence for the effectiveness of topical agents (antimicrobial and non-antimicrobial) in vivo (humans). Sorbact is approved by the Therapeutic Goods Administration (TGA) in Australia for use in wounds. It does not contain any active antimicrobial agents that kill bacteria, rather the main ingredient (Dialkylcarbamoyl chloride) binds bacteria to the dressing. The bacteria is therefore removed at each dressing change.

In this proof of concept study we plan on seeing if the dressing can attract and adhere bacterial biofilm in patients with chronic diabetic foot ulcers. We plan on recruiting 20 participants for a study period of two weeks, and collect pre-and-post treatment tissue samples, soiled dressings and wound swabs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108106 0
Dr Matthew Malone
Address 108106 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170 NSW
Country 108106 0
Australia
Phone 108106 0
+61 02 8738 9260
Fax 108106 0
+61 2 8738 8297
Email 108106 0
[email protected]
Contact person for public queries
Name 108107 0
Ms Saskia Schwarzer
Address 108107 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170 NSW
Country 108107 0
Australia
Phone 108107 0
+61 2 8738 9262
Fax 108107 0
+61 2 8738 8297
Email 108107 0
[email protected]
Contact person for scientific queries
Name 108108 0
Dr Matthew Malone
Address 108108 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170 NSW
Country 108108 0
Australia
Phone 108108 0
+61 02 8738 9260
Fax 108108 0
+61 2 8738 8297
Email 108108 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.