RecruitingACTRN12621000293864

The effects of Sorbact on diabetic foot ulcers with suspected biofilm infections.

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

Sponsor

South Western Sydney Local Health District

Enrollment

20 participants

Start Date

Feb 8, 2021

Study Type

Interventional

Conditions

Biofilm infections Diabetic Foot Ulcer

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Diabetic foot ulcers are open wounds that can be very difficult to heal, particularly when bacteria form a protective layer called a biofilm. Biofilms make bacteria much harder to kill with antibiotics or antiseptics. Sorbact is a special wound dressing that does not use any antimicrobial agents — instead, it physically attracts and binds bacteria to its surface so that they are removed every time the dressing is changed. This proof-of-concept study is testing whether Sorbact dressings can attract and remove biofilm bacteria from diabetic foot ulcers. Twenty participants with type 1 or type 2 diabetes will be recruited. To be eligible, you must have a diabetic foot ulcer that has not been healing for over six weeks (despite treatment), with signs that a biofilm infection may be present, such as resistance to antibiotics or excessive wound moisture. Participants will use the Sorbact dressing for two weeks, and researchers will collect tissue samples, wound swabs, and used dressings before and after treatment to measure whether biofilm levels change. This study could provide important early evidence to support the use of a novel, antibiotic-free approach to treating chronic, infected diabetic foot ulcers — a condition that can ultimately lead to amputation if not managed well.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.