ANZCTR - Registration

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]

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

Biofilm infections

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Skin

Other skin conditions

Infection

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]

Treatment: Devices

Intervention code [2]

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]

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]

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]

To assess the microbial load of diabetic foot ulcer tissue before and after therapy through 16S rRNA sequencing.

Timepoint [1]

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]

Explore the bacterial diversity present in and on diabetic foot ulcer tissue before and after therapy through 16S rRNA sequencing.

Timepoint [2]

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]

To assess the microbial load of a DACC-coated mesh dressing, before and after therapy with 16S rRNA sequencing.

Timepoint [3]

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]

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]

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]

Explore the bacterial diversity present in and on the DACC-coated mesh dressing before and after therapy through 16S rRNA sequencing.

Timepoint [5]

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]

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]

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]

Assess the spatial organization of microbial aggregates in tissue with Peptide nucleic acid fluorescent in situ hybridization (PNA-FISH)

Timepoint [7]

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]

Confirm the presence of biofilm within the wound with Scanning electron microscopy (SEM)

Timepoint [8]

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

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]

Liverpool Hospital - Liverpool

Recruitment hospital [2]

Dandenong Hospital - Dandenong

Recruitment hospital [3]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

2170 - Liverpool

Recruitment postcode(s) [2]

3175 - Dandenong

Recruitment postcode(s) [3]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Abigo Medical AB

Country [1]

Sweden

Primary sponsor type

Government body

Name

South Western Sydney Local Health District

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

South West Sydney Limb Preservation and Wound Research

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Ethics Committee

Ethics committee address [1]

Research and Ethics Office
Locked Bag 7103
LIVERPOOL BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/10/2020

Approval date [1]

25/11/2020

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Matthew Malone

Address

Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170 NSW

Country

Australia

Phone

+61 02 8738 9260

Email

[email protected]

Contact person for public queries

Name

Saskia Schwarzer

Address

Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170 NSW

Country

Australia

Phone

+61 2 8738 9262

Email

[email protected]

Contact person for scientific queries

Name

Matthew Malone

Address

Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170 NSW

Country

Australia

Phone

+61 02 8738 9260

Email

[email protected]

Trial Review

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